Identity
- Trade Name
- RAMP® Cardiac Controls - Level 2 FDA UDI
- Generic Name
- Multiple cardiac marker IVD, control FDA UDI
- Model / Reference
- C5003-2 FDA UDI
Identifiers
- Catalog Number
- C5003-2 FDA UDI
- Primary DI / UDI-DI
- 10627966005305 FDA UDI
- 510(k) Number
- K080973 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple cardiac marker IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple cardiac marker IVD, control
RAMP® Cardiac Controls - Level 2 by Response Biomedical Corp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple cardiac marker IVD, control.
- Audit MicroControls Linearity FLQ Cardiac Markers for Roche Systems — Aalto Scientific, Ltd.
- Audit MicroControls Linearity FD Cardiac Markers for Roche Systems — Aalto Scientific, Ltd.
- CARDIAC MARKER CONTROL TRI-LVL — CLINIQA CORPORATION
- Liquichek — Bio-Rad Laboratories · Class I
- Audit MicroControls Linearity FD Cardiac Markers for Ortho Vitros — Aalto Scientific, Ltd.
- Cardiac Calibration Verifiers for Beckman Systems — CLINIQA CORPORATION · Class I
- Liquichek — Bio-Rad Laboratories · Class I
- Liquichek — Bio-Rad Laboratories · Class I
Cleared under the same submission
K080973 also covers:
- CARDIAC MARKER CONTROL LEVEL 3 — CLINIQA CORPORATION
- Cardiac Calibration Verifiers for Beckman Systems — CLINIQA CORPORATION
- Cardiac Calibration Verifiers for Roche Systems — CLINIQA CORPORATION
- Cardiac Control Complete +TnT level 1 — CLINIQA CORPORATION
- Cardiac Control Complete +TnT level 2 — CLINIQA CORPORATION
- Cardiac Control Complete +TnT level 3 — CLINIQA CORPORATION
- Cardiac Marker Complete Level 2 — CLINIQA CORPORATION
- LQC Cardiac Control CS, Tri-level kit — CLINIQA CORPORATION
- Liquid QC Cardiac Marker Control Complete Level 1 — CLINIQA CORPORATION
- RAMP® Cardiac Controls - Level 1 — Response Biomedical Corp
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Response Biomedical Corp
Sources (1)
- FDA UDI fff3e5ac-b935-400b-8fa4-ceeca846d001 34 fields · synced May 30, 2026