Who else makes this device?

Name: MAS OmniCORE Max, Level 1
Brand: MAS OmniCORE Max, Level 1

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

MAS OmniCORE Max, Level 1

Catalogue number OCRM-101, listed by Microgenics Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

6510(k) clearances naming this product code

6recalls 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 MAS OmniCORE Max, Level 1
Listed by	Microgenics Corporation, 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, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2025-06-27

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for MAS OmniCORE Max, Level 1
Catalogue number	Size	Status
OCRM-101		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
K122291	2012-08-31
K110738	2011-11-03
K110616	2011-06-29
K092051	2009-09-21
K061196	2006-05-30
K041073	2004-05-21

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. 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
2025-10-01	Class II	Nonconforming Material/Component	The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.	4462
2014-10-20	Class II	Nonconforming Material/Component	MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32).	2135 vials.	2015-03-30
2013-12-02	Class III	Labeling Change Control	The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change.	1393	2014-07-08
2013-12-02	Class III	Labeling Change Control	The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change.	3185	2014-07-08
2012-08-20	Class III	Nonconforming Material/Component	In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.	2076 total in US , 596 total Foreign	2013-03-04
2011-12-14	Not classified	Nonconforming Material/Component	Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges.	25,113 Kits	2012-10-26

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.