Multi-Analyte Controls, All Kinds (Assayed)

Which Manufacturers in China Make This?

The one Chinese manufacturer registered for this device type is based in Jiangsu.

Getein Biotech, Inc. Jiangsu

What Is FDA Product Code JJY?

Multi-Analyte Controls, All Kinds (Assayed) is FDA product code JJY, Class 1, 21 CFR 862.1660.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 91 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (8), Employee error (6) and Labeling Change Control (5).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Multi-Analyte Controls, All Kinds (Assayed)

Cardiac Control – Level 3 (CRD Control 3)

Catalogue number CQ10431, listed by Randox Laboratories Limited, United Kingdom, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

V8 SP Normal Control (10 X 2 Ml)

Catalogue number 1810, listed by Helena Laboratories, Corp., United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Ser-T-Fy 2, Level 2 Control

Use as a control serum to monitor the accuracy and precision of manual and automated methods used in clinical chemistry.

Multi-Analyte Controls, All Kinds (Assayed)

EliA Thyroid Positive Control 250

Catalogue number 83-0018-01, listed by Phadia AB, Sweden, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

DImension Vista® Protein 2 Control H

PROT2 CON H is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of ASL, CRP and RF methods on the Dimension Vista® System

Multi-Analyte Controls, All Kinds (Assayed)

Whole Blood Volatiles Conttrol Level 2

Catalogue number 93222, listed by Cliniqa Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Pointe Scientific Ammonia/Alcohol Controls

"For in vitro diagnostic use only. The Pointe Scientific, Inc. Ammonia / Alcohol Control set is to be used for monitoring the accuracy and precision of various ammonia and / or ethanol…

Multi-Analyte Controls, All Kinds (Assayed)

V8 Serum Protein SPE Kit (500 Tests)

Catalogue number 1805, listed by Helena Laboratories, Corp., United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Lung Marker Control

Catalogue number 240-20, listed by Fujirebio Diagnostics, AB, Sweden, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Avox-4 CO-Oximeter Control – L3

Avox-4 CO-Oximeter Control, Level 3

Multi-Analyte Controls, All Kinds (Assayed)

Yumizen C1200 U/CSF L1 Micro Alb Control

Catalogue number 1300023948, listed by Horiba ABX SAS, France, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

EliA ANA Positive Control 100

Catalogue number 83-0006-91, listed by Phadia AB, Sweden, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Pointe Scientific Chemistry Control, Level 2

Catalogue number C7591-50, listed by Horiba Instruments Incorporated, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

ImmunoCAP Specific IgG Conjugate 50

Catalogue number 34-2271-71, listed by Phadia AB, Sweden, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Hi Res Protein Marker

Catalogue number 5141, listed by Helena Laboratories, Corp., United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

hsCRP Serum Protein Control Level 1

Catalogue number 91201, listed by Cliniqa Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Multi-4 CO-Oximeter Control, Level 2

Catalogue number 00003314250, listed by Instrumentation Laboratory SPA, Italy, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

ImmunoCAP Thyroid Peroxidase IgG Antibodies Control NLH

Contains 2 vials of each IgG antibodies level (N: normal; L: low; H: high) for the ImmunoCAP Thyroid Peroxidase method.

Multi-Analyte Controls, All Kinds (Assayed)

DImension Vista® Protein 2 Control L

PROT2 CON L is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of ASL, CRP and RF methods on the Dimension Vista® System

Multi-Analyte Controls, All Kinds (Assayed)

Ramp® Cardiac Controls – Level 1

The RAMP® Cardiac Controls are prepared from human plasma, human serum and human proteins. Preservatives and stabilizers have been added to maintain product integrity. The RAMP® Cardiac…

Multi-Analyte Controls, All Kinds (Assayed)

CSF Control – Level 2 (CSF Control 2)

This product is intended for in vitro diagnostic use, in the quality control of diagnostic methods using CSF as a sample on clinical chemistry systems. The CSF controls are for the control…

Multi-Analyte Controls, All Kinds (Assayed)

Assay Control Serum Level 1

Catalogue number R83082, listed by Cliniqa Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Ramp® Cardiac Controls – Level 2

The RAMP® Cardiac Controls are prepared from human plasma, human serum and human proteins. Preservatives and stabilizers have been added to maintain product integrity. The RAMP® Cardiac…

Multi-Analyte Controls, All Kinds (Assayed)

MedTest DX Control Level 2

MedTest DX Control Level 2 is a lyophilized human based control serum for use in the quality control of diagnostic assays. Human-sera can be supplied as an assayed serum for control of…

Multi-Analyte Controls, All Kinds (Assayed)

ImmuTROL Serum Protein Contrl Tri-Level (Level 1,2 & 3)

Catalogue number 91104, listed by Cliniqa Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Yumizen C1200 P Multi Control

Catalogue number 13000023940, listed by Horiba ABX SAS, France, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Cardiac Marker Complete Level 2

Cardiac Marker Control +TnI Level 2

Multi-Analyte Controls, All Kinds (Assayed)

QuanTscopics Control Level 1 Set 4x120ml

The QuanTscopics Urinalysis Microscopics Control is intended for use as quality control material for the microscopic evaluation of various urine sediment methods. It is supplied in two…

Multi-Analyte Controls, All Kinds (Assayed)

TriVerity Mini Verification Panel

The TriVerity Mini Verification panel is intended solely for use with the TriVerity Test System for verification and training purposes. The TriVerity Mini-Verification Panel contains…

Multi-Analyte Controls, All Kinds (Assayed)

Tumor Marker Control Level 1

Catalogue number 91301, listed by Cliniqa Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Bi-Level Hgb Controls

A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin testing system.

Multi-Analyte Controls, All Kinds (Assayed)

Yumizen C1200 Level 1 CRPhs Control

Catalogue number 1300071247, listed by Horiba ABX SAS, France, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

905-918 ABL90 Flex Flush Device

Flush device for ABL90 FLEX

Multi-Analyte Controls, All Kinds (Assayed)

Pointe Scientific, Inc.

For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly…

Multi-Analyte Controls, All Kinds (Assayed)

MedTest DX, Inc. Lipid Controls

The Lipid Control set are assayed Lipid Controls produced from fresh human sera to monitor the accuracy and precision of quantitative lipid determinations of human sera specimens. 6 x 3 ml

Multi-Analyte Controls, All Kinds (Assayed)

Apolipoprotein Control – Level 3 (APO Control 3)

Catalogue number LE5018, listed by Randox Laboratories Limited, United Kingdom, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

MedTest DX Control Level 1

MedTest DX Control Level 1 is a lyophilized human based control serum for use in the quality control of diagnostic assays. Human-sera can be supplied as an assayed serum for control of…

Multi-Analyte Controls, All Kinds (Assayed)

Immunoassay Premium Plus – Level 2 (IA Premium Plus 2)

Catalogue number IA3110, listed by Randox Laboratories Limited, United Kingdom, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Cardiac Control Complete +TnT Level 3

Catalogue number 91492, listed by Cliniqa Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Avox-4 CO-Oximeter Control – L2

Avox-4 CO-Oximeter Control, Level 2

Multi-Analyte Controls, All Kinds (Assayed)

LipoTrol (5 X 1 Ml)

Catalogue number 5069, listed by Helena Laboratories, Corp., United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

CRP (C-Reactive Protein)

Catalogue number 75-5442, listed by Microgenics Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

EliA ANA 3 Positive Control 2500/5000

Catalogue number 83-0041-21, listed by Phadia AB, Sweden, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Mission Trinity B Level 1-2-3

Catalogue number DD-96123, listed by Diamond Diagnostics Inc., Hungary, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Rapidqc® Complete Level 2

Catalogue number 10309926, listed by Siemens Healthcare Diagnostics Inc, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Tri-Level Immunoassay Control Minipack

Catalogue number 94109, listed by Cliniqa Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

EasyRA Analyzer (ISE&LIS)

EasyRA Analyzer - ISE & LIS

Multi-Analyte Controls, All Kinds (Assayed)

Immunoassay Control Level 3

Catalogue number 94103, listed by Cliniqa Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

TriVerity Level 1 Quality Control

The TriVerity Quality Controls are intended for use as optional quality control materials to assess the performance of the TriVerity Test System. TriVerity Quality Controls are designed to…

Multi-Analyte Controls, All Kinds (Assayed)

MAS Immunology Advanced Level 3

Catalogue number ICA-303, listed by Microgenics Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Apolipoprotein Control – Level 2 (APO Control 2)

Catalogue number LE5017, listed by Randox Laboratories Limited, United Kingdom, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Aptiva® Celiac Disease IgA Controls

The Celiac Disease IgA Controls include antibodies to tTG and DGP 1. Aptiva Celiac IgA Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain…

Multi-Analyte Controls, All Kinds (Assayed)

Yumizen C Urine Level 1 Control

Catalogue number 1300023946, listed by Horiba ABX SAS, France, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

ABX Pentra P Control

Catalogue number 1220001654, listed by Horiba ABX SAS, France, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

CO2/ELECTROLYTE Linearity Verifiers (For Roche Systems) (CO2 LIN VER)

CO2/Electrolyte Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of the Roche Systems for Carbon Dioxide, Sodium, Potassium, and Chloride.

Multi-Analyte Controls, All Kinds (Assayed)

Autocheck 6+, Level 3, S7855

S7855 AutoCheck 6+, level 3 box of 30 ampoules, for ABL8XX

Multi-Analyte Controls, All Kinds (Assayed)

Assayed Bovine Multi Sera – Level 1 (BOV ASY Control 1)

Catalogue number AL1027, listed by Randox Laboratories Limited, United Kingdom, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Coagulation Control – Level 3 (Coag Control 3)

Catalogue number CG5023, listed by Randox Laboratories Limited, United Kingdom, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Direct Lipid Control L1

Catalogue number 3001, listed by Medtest DX, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

DImension Vista® High Sensitivity CRP Control H (High)

For use as an assayed intralaboratory control for assessment of precision and analytical bias in the determination of the hsCRP method on the Dimension Vista® System

Multi-Analyte Controls, All Kinds (Assayed)

ImmuTROL Serum Protein Control-Bi-Level (Level 1 & 3)

Catalogue number 91105, listed by Cliniqa Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

ImmuTROL Serum Protein Contrl Level 2

Catalogue number 91102, listed by Cliniqa Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Cardiac Calibration Verifiers for Roche Systems

Catalogue number 98505, listed by Cliniqa Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Platelet PGDprime Negative Control

Platelet PGDprime Negative Control for quality control testing of the Platelet PGDprime Test System.

Multi-Analyte Controls, All Kinds (Assayed)

Assay Control Serum Level 2

Catalogue number R83083, listed by Cliniqa Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

ABX Pentra Micro ALB Control L/H

Catalogue number 1220001967, listed by Horiba ABX SAS, France, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Apolipoprotein Control Serum CHD

Assayed control for apolipoprotein A-I and B and CRP assays on BN Systems

Multi-Analyte Controls, All Kinds (Assayed)

K-Assay® Liquid Lipid Control

Catalogue number K110C-2M, listed by Kamiya Biomedical Company LLC, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

ContrIL 7 Multipak

Catalogue number 00024001380, listed by Instrumentation Laboratory SPA, Italy, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

EliA IgG/IgM/IgA Negative Control 2500/5000

Catalogue number 83-0009-11, listed by Phadia AB, Sweden, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Direct Lipid Control L3

Catalogue number 3003, listed by Medtest DX, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Immunoassay Premium Plus – TRI-Level (IA Premium Plus 1, 2 AND 3)

Catalogue number IA3112, listed by Randox Laboratories Limited, United Kingdom, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Liquid Frozen Lipid Control – Level 3 (LIQ LPD Control 3)

Catalogue number LE10176, listed by Randox Laboratories Limited, United Kingdom, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

EliA IgM Curve Control

Catalogue number 83-0006-01, listed by Phadia AB, Sweden, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

GEM ChemSTAT PVP 1-5

GEM ChemSTAT PVP1-5, 5 levels x 5 ampoules x 1.8 mL

Multi-Analyte Controls, All Kinds (Assayed)

Coagulation Control – Level 2 (Coag Control 2)

Catalogue number CG5022, listed by Randox Laboratories Limited, United Kingdom, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Chemistry Premium – Level 3 (Chem Premium 3)

Catalogue number HE5068, listed by Randox Laboratories Limited, United Kingdom, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Liquid CSF Control – Level 1 (CSF Control 1)

Catalogue number CF10138, listed by Randox Laboratories Limited, United Kingdom, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Platelet PGDprime Controls

Platelet PGDprime Positive and Negative Controls for quality control testing of the Platelet PGDprime Test System.

Multi-Analyte Controls, All Kinds (Assayed)

Monobind Qsure Maternal Control Set

Catalogue number MC-300, listed by Monobind, Inc., United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Multi-Analyte Controls, All Kinds (Assayed)

Which Manufacturers in China Make This?

What Is FDA Product Code JJY?

What Does It Take to Sell It in the United States?

What Do the Recalls Say?

Where China Actually Supplies