Identity
- Trade Name
- Cardiac CalVer for Abbott Systems, Level A-E FDA UDI
- Generic Name
- Multiple cardiac marker IVD, control FDA UDI
- Device Name
- LiniCAL Cardiac CalVer for Abbott Systems, Level A LiniCAL Cardiac CalVer for Abbott Systems, Level B LiniCAL Cardiac CalVer for Abbott Systems, Level C LiniCAL Cardiac CalVer for Abbott Systems, Level D LiniCAL Cardiac CalVer for Abbott Systems, Level E FDA UDI
- Model / Reference
- 98602 FDA UDI
- Description
- LiniCAL Cardiac CalVer for Abbott Systems, Level A LiniCAL Cardiac CalVer for Abbott Systems, Level B LiniCAL Cardiac CalVer for Abbott Systems, Level C LiniCAL Cardiac CalVer for Abbott Systems, Level D LiniCAL Cardiac CalVer for Abbott Systems, Level E FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817238010028 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Cardiac CalVer for Abbott Systems, Level A-E by Cliniqa Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- RAMP® Cardiac Controls - Level 2 — 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 |
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Manufacturer
- Manufacturer
- Cliniqa Corporation
Sources (1)
- FDA UDI de7a5774-f0b2-4446-9cc3-7e86d1eed62d 35 fields · synced May 30, 2026