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Test, Albumin Cobalt Binding

FDA product code NJV · 2 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1215
Review panel
CH
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2003-02-14 – 2005-12-16

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.

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