Product code GRE
- Device name
- Antiserum, Fluorescent, Rubeola
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3520
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884004 | RUBEOLA TEST | Gull Laboratories, Inc. | 1988-12-05 |
| K853067 | FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT | Idt, A Division of Whittaker M.A. Bioproducts | 1985-10-22 |
| K821249 | ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS | Electro-Nucleonics Laboratories, Inc. | 1982-07-30 |
| K770687 | MEASLESVIRUS FLOURE. CONJUGATED ANTISERU | Microbiological Assoc. | 1977-06-14 |
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