NJV
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Test, Albumin Cobalt Binding
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- FDA definition
- The Albumin Cobalt Binding Test is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with other tests such as ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) (K053196) | Inverness Medical Innovations, Inc. | 2005-12-16 |
| ALBUMIN COBALT BINDING TEST (ACB TEST) (K023824) | Ischemia Technologies, Inc. | 2003-02-14 |
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Every clearance here is in the API, with alerts when new ones post.