ChemSTAT System Evaluator 2
ChemSTAT System Evaluator 2, 10 ampoules x 1.8 mL
Precision Xtra
Precision Xtra Blood Glucose & Ketone Monitoring System
Sofia
The listed hCG FIA corresponds to the Sofia hCG FIA named in the FDA filing. The filing describes it as an immunofluorescence-based lateral-flow assay for qualitative detection of human…
Dimension Vista® Flex® Reagent Cartridge Trig
Triglyceride Flex® reagent cartridge, 600 tests
MAS Omni•IMMUNE PRO Max, Level 2
Catalogue number OPROM-202, listed by Microgenics Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.
DropStrip Urinalysis Control Bi-Level
Catalogue number 97202, listed by Cliniqa Corporation, United States, under Urinalysis Controls (Assayed And Unassayed). 3 manufacturers in China are registered for this product code.
Spinalscopics Control Level 2 Set 3x3ml
Spinalscopics Spinal Fluid Cell Count Control is intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in…
C-Peptide Elisa
The DRG C-Peptide ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of C-Peptide in serum, plasma (EDTA, lithium heparin or citrate plasma) and urine.
Advia Centaur® aCCP IgG MCM
Anti-CCP IgG (aCCP) MCM
LetsGetChecked Blood Sample Collection Kit (Mhtb)
2 catalogue numbers from BO12S, listed by Privapath Diagnostics Ltd, Ireland, under Blood Specimen Collection Convenience Kit (Excludes Hiv). 1 manufacturer in China is registered for this product code.
Pointe Scientific
AST Reagent Set for the quantitative determination of Aspartate Aminotransferase (AST) in human serum. Packaged at 5 x 100ml, 2 x 55ml
EliA IgG/IgM/IgA Negative Control 250
Catalogue number 83-0006-81, listed by Phadia AB, Sweden, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.
Glycerol Control (GLY Control)
Catalogue number GY1369, listed by Randox Laboratories Limited, United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.
ACE Elevated Control
Catalogue number SC-131EL, listed by Analytical Control Systems, United States, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.
MAS Omni•IMMUNE PRO Max, Level 3
Catalogue number OPROM-303, listed by Microgenics Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.
Easy@Home Ovulation Test Kit (15 LH Strips + 5 HCG Strips)
15LH strips +5HCG strips ;Ovulation Test Kit
Advia Centaur® FER MCM
Ferritin Master Curve Material Set - CENTAUR - CONS
Accutrend Glucose Test Strips
Catalogue number 11447475160, listed by Roche Diagnostics Gmbh, Germany, under Glucose Oxidase, Glucose. 8 manufacturers in China are registered for this product code.
CVS Health Digital Pregnancy Test
CB8 Digital Pregnancy Stick CVS DPS Digital Early (ER)
Progesterone AccuLite Clia Test System – 96 Wells
Catalogue number 4875-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.
Blood Gas and Electrolyte Control
3 catalogue numbers from Level 3, listed by Edan Instruments, Inc., China, under Controls For Blood-Gases, (Assayed And Unassayed). 1 manufacturer in China is registered for this product code.
RAPIDChem® 754 Na+K+Li+ Reagent Module
RAPIDChem® 754 Na+ K+ Li+ Reagent Module, for in vitro diagnostics use with the Rapidchem® 754 systems.
Element™Plus Meter
Catalogue number IGM-0021B, listed by Osang Healthcare Co., Ltd., South Korea, under Glucose Oxidase, Glucose. 8 manufacturers in China are registered for this product code.
Fully-Automated Urine Chemistry Analyzer
Catalogue number DxU 1800c,1 unit, listed by Urit Medical Electronic Co., Ltd., China, under Enzymatic Method, Creatinine. 4 manufacturers in China are registered for this product code.
STAT-Site M B-HB Analyzer Pack
The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the…
CareLiving MM1100 Blood Glucose Meter
CareLiving MM1100 Meter
Calibration Solution 1
S1820 Calibration Solution 1, 200 mL, for ABL800 FLEX
Safecare Vaginal PH Rapid Test Cassette
2 catalogue numbers from 5 Tests, listed by Safecare Biotech(Hangzhou)Co., Ltd., China, under Paper, Obstetric Ph. 13 manufacturers in China are registered for this product code.
Monarch 21g BCS
Safety Blood collection set 21g, 3/4" Needle, 12" tubing, with luer lock holder
TSH CalCheck 5
Catalogue number 05917824160, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.
Dimension® TP/ALB Calibrator
Total Protein/Albumin Calibrator, 2x3x2mL
Monobind AccuLite FSH, hCG, LH & PRLs Vast Clia Kit – 960 Wells
3 catalogue numbers from 8375-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.
Stat Profile
Stat Profile Critical Care Xpress Co-Oximeter S-Line Probe Assembly
Aptiva® APS IgG Controls
1.Aptiva APS IgG Control 1 (2x 0.5mL) 2. Aptiva APS IgG Control 2 (2x 0.5mL)
GEM Premier 3000 iQM – BG HCT Elect. – 450 Tests
GEM Premier 3000 iQM 3WK - BG HCT ELECT. - 450 Tests
Cholesterol
PTS Panels® cholesterol self-test strips are for the quantitative measurement of total cholesterol in capillary whole blood from the fingertip. Cholesterol measurements are used in the…
Phoenix Diagnostics
LiquiCV MA - Multi-Analyte Linearity Control
Pointe Scientific ALT (Sgpt) Liquid
3 catalogue numbers from A7526-625, listed by Horiba Instruments Incorporated, United States, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.
Dimension® Flex® Reagent Cartridge Aldl
Automated LDL Cholesterol Flex® reagent cartridge, 120 tests
TruePoint
5 catalogue numbers from 64240, listed by OK Biotech Co., Ltd., Taiwan, under System, Test, Blood Glucose, Over The Counter. 20 manufacturers in China are registered for this product code.
Instant-View LH Ovulation Predicting Dip-Strip Test
Catalogue number 02-2547, listed by Alfa Scientific Designs, Inc., United States, under Radioimmunoassay, Luteinizing Hormone. 16 manufacturers in China are registered for this product code.
Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-240
Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-240 is used for the quantitative determination of uric acid in serum or plasma on the TC-Matrix-240 analyzer.
SampLok® Adapter Cap 3
The SampLok® Adapter Cap has a Luer thread which facilitates attachment with commonly available multi-sample Luer adaptor; It is intended to facilitate collection of blood sample into…
BABYLife
1-Digital Midstream; BABYlife™ hCG Pregnancy Test Digital Midstream 25mIU/mL, 1 Test per Kitbox
Frend Testosterone Linearity Kit
FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity material for the testosterone on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™…
Variant II Turbo
VARIANT II TURBO HbA1c Kit - 2.0
Alltara Zephyr!
Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters
Kurin Blood Collection Set, 23 Ga, BD Vacutainer
Catalogue number D-11223, listed by Pathway Medical Technologies, Inc., United States, under Tubes, Vials, Systems, Serum Separators, Blood Collection. 23 manufacturers in China are registered for this product code.
Total Triiodothyronine (Tt3) Elisa
The Quantitative Determination of Free Triiodothyronine Concentration in Human Serum by a Microplate Enzyme Immunoassay. Levels of fT3 are thought to reflect the amount of T3 available to…
ST AIA-Pack C-Peptide II
ST AIA-Pack C-Peptide II: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.
Direct Lipid Control Set
Catalogue number 3000, listed by Medtest DX, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.
Immulite® Systems HCY Calibration Verification Material Homocysteine
Homocysteine CVM - IMMULITE - CONS
Nova Lite® IFA Yo (PCA-1) Positive Control
1 x 0.5mL Yo (PCA-1) Positive Control
GEM CVP (Calibration Valuation Product) 5 Tbili
Catalogue number 00025000145, listed by Instrumentation Laboratory SPA, Italy, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.
Cobas B 123 Sensor Cartridge BG/ISE
Catalogue number 05170460001, listed by Roche Diagnostics Gmbh, Germany, under Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph. 1 manufacturer in China is registered for this product code.
Spotchem™ II Lipid Panel
Strip description for the invitro quantitative determination of HDL-cholesterol, total cholesterol, and triglyceride in human plasma from whole blood samples
Follicle-Stimulating Hormone (FSH) Menopause Test
This product is used for qualitative detection of Follicle-Stimulating Hormone (FSH) in the urine for women who are preparing for pregnancyand are interested in assessing their fertility.…
Wellue
2 catalogue numbers from Bioland, listed by Bioland Technology Ltd., China, under System, Test, Blood Glucose, Over The Counter. 20 manufacturers in China are registered for this product code.
AutoDELFIA Inhibin a Kit
Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.
AccuDiag™ Free Estriol Elisa
AccuDiag™ Free Estriol ELISA A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free estriol (oestriol) in a…
Advia Centaur® Calibrator B
Total HCG B (6PK) (Ref) - CENTAUR - CAL - 6x2x5mL
Accu-Chek Smart View
Accu-Chek Smart View Control 6/CS
ST AIA-Pack BetaHCG
ST AIA-Pack BetaHCG: 1 catalogue number listed by Tosoh Corp., Japan, under Visual, Pregnancy Hcg, Prescription Use. 16 manufacturers in China are registered for this product code.
Vitros
VITROS Immunodiagnostic Products FSH Reagent Pack
Sample Detector
Catalogue number ME-2257D, listed by Diamond Diagnostics Inc., Hungary, under Electrode, Ion Specific, Potassium. 2 manufacturers in China are registered for this product code.
Dimension® Pbnp Calibrator
N-Terminal Pro-Brain Natriuretic Peptide Calibrator, 2x5x1mL
HemosIL AcuStar Anti-Cardiolipin IgM Controls
Catalogue number 0009802108, listed by Instrumentation Laboratory SPA, Italy, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.
Freelite® Human Lambda Free Control Pack for Use on the Siemens Bn™ii
4 catalogue numbers from NQ018.T, listed by The Binding Site Group Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.
Frend TSH
It is used for the quantitative determination of Thyroid Stimulating Hormone in human specimen using FREND System.
Membrane-Adapter
Catalogue number 14.1112, listed by Sarstedt Aktiengesellschaft & Co.KG, under Tubes, Vials, Systems, Serum Separators, Blood Collection. 23 manufacturers in China are registered for this product code.
Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump Users
The Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who…
AmmoniaEthanolCO2 Control N AmmoniaEthanolCO2 Control Normal
Catalogue number 20752401190, listed by Roche Diagnostics Gmbh, Germany, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.
Pregnancy (hCG) Urine/Serum Combo Rapid Test Cassette
Pregnancy (hCG) Urine/Serum Combo Rapid Test Cassette: 1 catalogue number listed by Acro Biotech Inc., United States, under Visual, Pregnancy Hcg, Prescription Use. 16 manufacturers in China are registered for this product code.
Glucose-SL
Catalogue number 235-99, listed by Sekisui Diagnostics, LLC, United States, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.
In Touch Glucose Control Solution
In Touch Control solution with 1 bottle high, 1 bottle low
Rapidpoint® 340/350 Po2 Electrode
RAPIDPOINT® 340/350 pO2 Electrode for use with Rapidpoint® 340/350 Analyzers.
Elecsys FT4 CalCheck
Catalogue number 11776665160, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.
Medline
Pregnancy Tests: HCG Combo Pregnancy Test, Cassette, 20 mIU/mL for Urine, 10 mIU/mL for Serum
BioSign® hCG S/U Card
BioSign® hCG S/U card; 35 Test kit; CE; E-device for Lifesign
MAS Omni-CORE Liquid Assayed Integrated Chemistry Control
4 catalogue numbers from OCR-101, listed by Microgenics Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.
Easy Trak Control Solution – High
Blood glucose control solution for use with Easy Trak blood glucose testing system
Aimstrip US-2
Dipstick reagent strips for the qualitative detection of Glucose & Protein in urine.
QMS Tacrolimus Immunoassay Calibrator Set
Catalogue number 10015573, listed by Microgenics Corporation, United States, under Calibrator, Secondary. 1 manufacturer in China is registered for this product code.
Oh’care Lite Smart Glucose Meter
The Oh’Care Lite Smart Glucose Meter measures blood glucose using compatible Oh’Care Lite Smart test strips. An electrical current generated in the strip is passed to the meter, which…
Biocoach Blood Glucose Test Strips 50s
Catalogue number S5640989, listed by Amventurex, Inc., under System, Test, Blood Glucose, Over The Counter. 20 manufacturers in China are registered for this product code.
Axis-Shield Homocysteine Controls
The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total L-homocysteine in human serum or…
Carolina Liquid Chemistries Corp.® Ucrea RGT. KIT BL-343
CREAu (Creatinine, Urine) only
Brilliant Care
2 catalogue numbers from TMB-2282-G, listed by MIO Labs Inc., United States, under System, Test, Blood Glucose, Over The Counter. 20 manufacturers in China are registered for this product code.
LDL Chol Reagent Kit
LDL Cholesterol Reagent Kit for use with EasyRA Analyzers
Pregnancy (hCG) Rapid Test Midstream
Catalogue number FHC-103H, listed by Hangzhou AllTest Biotech Co., Ltd., China, under Kit, Test, Pregnancy, Hcg, Over The Counter. 30 manufacturers in China are registered for this product code.
Membrane for E7077 Electrode
D7077 Lac membrane box (4 units) for ABL7XX/8XX
BD Microtainer® Tubes With LH (Lithium Heparin)
Catalogue number 365965, listed by Becton, Dickinson AND Company, United States, under Tubes, Vials, Systems, Serum Separators, Blood Collection. 23 manufacturers in China are registered for this product code.
Dimension® Flex® Reagent Cartridge Phos
Phosphorus Flex® reagent cartridge, 480 tests
Stratus® CS Acute Care™ Ckmb CalPak
The Stratus® CS Acute Care (TM) CKMB Calibrator (CKMB CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care (TM) CKMB method.
GlucoLeader Enhance Blood Glucose Test Strip
GlucoLeader Enhance GL Blood Glucose Test Strip
Aldolase Level 2 Control (ALS Control 2)
Catalogue number AD5001, listed by Randox Laboratories Limited, United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.
Yumizen C1200 C02 Control
Catalogue number 1300023950, listed by Horiba ABX SAS, France, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.
GenaCheck Rapid Self-Test Kit for Urinary Tract Infections
Catalogue number RA9-E01802, listed by Genabio Diagnostics Inc, United States, under Diazo (Colorimetric), Nitrite (Urinary, Non-Quant). 14 manufacturers in China are registered for this product code.
Assure® Platinum Blood Glucose Test Strips
2 catalogue numbers from 500050 500100, listed by Arkray USA, Inc., United States, under Glucose Oxidase, Glucose. 8 manufacturers in China are registered for this product code.
Shinetell Plus Digital Pregnancy Test
Shinetell Plus Digital Early Pregnancy Test detects human chorionic gonadotropin in urine as an aid to detecting pregnancy. It is an over-the-counter test with an absorbent sample tip and…
MaYa
Catalogue number midstream, listed by Weihai Kangzhou Biotechnology Engineering Co., Ltd., China, under Kit, Test, Pregnancy, Hcg, Over The Counter. 30 manufacturers in China are registered for this product code.
Biobase
4 catalogue numbers from R1:20mL×1 R2:5mL×1, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.
AccuTrak
AccuTrak T-Uptake Calibration Verification Panel