Recognized standard
MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17
FDA recognition 7-232 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-232 |
|---|---|
| Designation | MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 |
| Title | Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jan 14, 2019 |
| Scope (excerpt) | Analysis of nucleic acids is playing an increasing role in the diagnosis and management of patients with hematopoietic neoplasms. The tests include those for detection of clonality by analysis of gene rearrangements in the antigen receptor genes or detection of nonrandom inactivation of the X… |
At a glance
- None 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: