Recognized standard
M16015_02_01
FDA recognition 14-612 · USP-NF · Sterility
Key facts
| Recognition number | 14-612 |
|---|---|
| Designation | M16015_02_01 |
| Title | <86> Bacterial Endotoxins Test Using Recombinant Reagents |
| Standards developer | United States Pharmacopeia (USP) and the National Formulary (NF) |
| Specialty area | Sterility |
| Date of entry | Dec 22, 2025 |
| Scope (excerpt) | The Bacterial Endotoxins Test (BET) described in this chapter contains additional techniques using nonanimal derived reagents to the Bacterial Endotoxins Test 85;. unless specified in an individual monograph, the tests in this chapter are considered alternative tests and must meet the requirements… |
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: