Recognized standard
D6499-18
FDA recognition 6-411 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-411 |
|---|---|
| Designation | D6499-18 |
| Title | Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | 1.1 This test method covers an immunological method to determine the amount of antigenic protein in Hevea Natural Rubber and its products using rabbit antisera specific for HNRL proteins. This immunoassay procedure quantitatively measures the level of antigenic latex proteins in solution using an… |
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: