Recognized standard
F2148-18
FDA recognition 2-264 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-264 |
|---|---|
| Designation | F2148-18 |
| Title | Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA). |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | 1.1 This practice provides a methodology to use a combination of in vivo and in situ procedures for the evaluation of delayed contact hypersensitivity reactions. 1.2 This practice is intended to provide an alternative to the use of guinea pigs for evaluation of the ability of a device material to… |
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: