Who else makes this device?

Clinical Chemistry › Test SystemsMulti-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…

Registry build 21.09.26

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 Controls are ready-to-use liquid control requiring no reconstitution or frozen storage.

1manufacturer

1catalogue number

1recall

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 Ramp® Cardiac Controls – Level 2
Listed by	Response Biomedical Corp., Canada
FDA product code	JJY
Device type	Multi-Analyte Controls, All Kinds (Assayed)
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Repacker / relabeller, Manufacturer
510(k)	K080973
Record published	2019-12-20
Record revised	2025-11-13 (version 2)

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
Storage	Special storage condition: RAMP® Cardiac Controls are stable until the expiration date on the vial when stored unopened at 2-8°C. Once opened, RAMP

Catalogue Numbers

Catalogue numbers for Ramp® Cardiac Controls – Level 2
Catalogue number	Size	Status
C5003-2	1 kit with 6 X 3 mL vials	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)

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. 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
2019-03-15	Class II	Device Design	The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac Control	543 units	2022-06-09

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.