Recognized standard
F2147-01 (Reapproved 2016)
FDA recognition 2-155 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-155 |
|---|---|
| Designation | F2147-01 (Reapproved 2016) |
| Title | Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Aug 21, 2017 |
| Scope (excerpt) | 1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity. 1.2 This practice is intended as an alternative to the Guinea Pig Maximization Test (GPMT), given the limitations on dosage form and tendency for false positives… |
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: