Who else makes this device?

Name: Pediatric Bilirubin Control Level 2 Set 3x3mL
Brand: Pediatric Bilirubin Control Level 2 Set 3x3mL

Clinical Chemistry › Test SystemsMulti-Analyte Controls, All Kinds (Assayed)

Pediatric Bilirubin Control Level 2 Set 3x3ml

The Pediatric Bilirubin Control is intended as a means of monitoring various bilirubin assay methods to validate quantitation of patient samples. It is supplied as a liquid, 3x3mL vials per…

Registry build 21.09.26

The Pediatric Bilirubin Control is intended as a means of monitoring various bilirubin assay methods to validate quantitation of patient samples. It is supplied as a liquid, 3x3mL vials per box. It is prepared from purified bilirubin in a human protein base, stabilizers and preservatives have been added.

1manufacturer

1catalogue number

7510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code JJY
Manufacturer	City	Province	Registered as	Device types
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19

Record

Regulatory record for Pediatric Bilirubin Control Level 2 Set 3x3mL
Listed by	Quantimetrix Corp., United States
FDA product code	JJY
Device type	Multi-Analyte Controls, All Kinds (Assayed)
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Contract manufacturer, Manufacturer, Exporter
510(k)	K860942
Record published	2018-09-26

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C; Handling environment temperature 18 to 25 °C

Catalogue Numbers

Catalogue numbers for Pediatric Bilirubin Control Level 2 Set 3x3mL
Catalogue number	Size	Status
1332-31		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Liquichek	Bio-Rad Laboratories Inc.	154
Validate	LGC Clinical Diagnostics, Inc.	120
InteliQ	Bio-Rad Laboratories Inc.	50
Lyphochek	Bio-Rad Laboratories Inc.	39
Stat Profile	Nova Biomedical Corporation	38
i-STAT	Abbott Point OF Care Inc.	24
Multichem AE	Techno-Path Manufacturing Ltd.	20
Serum Control	Chromsystems Instruments & Chemicals Gmbh	18
BioPlex 2200	Bio-Rad Laboratories Inc.	16
Nova	Nova Biomedical Corporation	14
Plasma Control	Chromsystems Instruments & Chemicals Gmbh	14
Multichem IA Speciality	Techno-Path Manufacturing Ltd.	12

Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K973894	1997-10-29
K970862	1997-04-08
K943394	1995-05-23
K925256	1993-03-01
K861420	1986-09-16
K860942	1986-05-23
K853931	1985-10-04

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2007-06-01	Not classified	Employee error	This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.	24,937 sets for all products.	2009-02-18
2007-06-01	Not classified	Employee error	This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.	24,937 sets for all products.	2009-02-18

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.