AccessGUDID - DEVICE: RAMP® CARDIAC CONTROLS; LEVEL 1 (10627966005077)

GUDID

Device Identifier (DI) Information

Brand Name: RAMP® CARDIAC CONTROLS; LEVEL 1
Version or Model: C2003-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C2003-1
Company Name: Response Biomedical Corp

Primary DI Number: 10627966005077
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 248609018 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47016	Multiple cardiac marker IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen. The cardiac markers may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: RAMP® Cardiac Controls are stable until the expiration date on the vial when stored unopened at 2-8°C. Once opened, RAMP® Cardiac Controls are stable for 30 days when stored tightly capped at 2-8°C

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1 test kit with 6 X 3 mL vials

Device Record Status

Public Device Record Key: 0e3680c7-a38e-4a84-b22a-376097d4991f
Public Version Date: November 14, 2025
Public Version Number: 5
DI Record Publish Date: August 31, 2017