Who else makes this device?

Name: Whole Blood Matrix
Brand: Whole Blood Matrix

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

Whole Blood Matrix

MORE DIAGNOSTICS Whole Blood Matrix is intended to be used as a whole blood matrix and zero level control product to check calibration in chemistry analyzers which measure everolimus,…

Registry build 21.09.26

MORE DIAGNOSTICS Whole Blood Matrix is intended to be used as a whole blood matrix and zero level control product to check calibration in chemistry analyzers which measure everolimus, rapamycin (sirolimus), tacrolimus, and cyclosporine.

1manufacturer

2catalogue numbers in this listing

3510(k) clearances naming this product 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 Whole Blood Matrix
Listed by	More Diagnostics Inc., United States
FDA product code	JJY
Device type	Multi-Analyte Controls, All Kinds (Assayed)
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2020-06-17

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature up to -14 °C

Catalogue Numbers

Catalogue numbers for Whole Blood Matrix
Catalogue number	Size	Status
375-B		In distribution
275-B		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
K050125	2005-03-18
K941876	1994-07-28
K941698	1994-07-28

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.