Recognized standard
C60-A
FDA recognition 7-48 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-48 |
|---|---|
| Designation | C60-A |
| Title | Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | The cost of alcohol abuse in our society is extraordinarily high in terms of the loss of human life, its detrimental contribution to the causes of illness and injury, productivity losses in the workplace, and the stress these in turn put on our medical resources and our judicial system. In a series… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: