GOL — Antigen, Ha (Including Ha Control), Rubella Class II
FDA Device Classification
Classification Details
- Product Code
- GOL
- Device Class
- Class II
- Regulation Number
- 866.3510
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K841174 | intl. diagnostic technology | RUBELLA ANTIBODY FLUOROIMMUNOASSAY | June 7, 1984 |
| K834032 | abbott laboratories | RUBAQUICK DIAGNOSTIC KIT | April 17, 1984 |
| K810309 | calbiochem-behring | RUBELLA ANTIBODIES TEST REAGENTS | March 11, 1981 |
| K802508 | m.a. bioproducts | RUBELISA IGM TEST KIT | December 18, 1980 |
| K802339 | beckman instruments | EIA RUBELLA-G | December 18, 1980 |
| K802102 | calbiochem-behring | RUBELLA ELISA REAGENTS RUBELLA IGG ANTI | December 18, 1980 |
| K801667 | clinical assays | GAMMA COAT(125 I) RUBELLA ANTIBODY | October 23, 1980 |
| K801098 | flow laboratories | ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) | September 16, 1980 |
| K801507 | ortho diagnostics | ANTIGEN CONTROL CELLS | August 20, 1980 |
| K800789 | litton bionetics | RUBELLA BIO-BEAD TITRATION KIT | June 30, 1980 |
| K800797 | bd becton dickinson vacutainer systems preanalytic | MACRO-VUE RUBELLA CARD TEST | June 20, 1980 |
| K792249 | intl. diagnostic technology | FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD | January 23, 1980 |
| K791610 | litton bionetics | RUBELLA BIO-BEAD SCREEN KIT | November 13, 1979 |
| K790976 | abbott laboratories | RUBAZYME | August 16, 1979 |
| K790212 | cordis | CORDIA T | April 12, 1979 |
| K780885 | cordis | CORDIA R | January 17, 1979 |
| K771796 | behring diagnostics | RUBA-NOST TEST KITS | October 18, 1977 |
| K770805 | flow laboratories | MEASLES-FA LABELLED (8-441 RF) | May 20, 1977 |
| K770809 | flow laboratories | MEASLES-FA LABELED PRESERUM (8-441 RNF) | May 20, 1977 |
| K770092 | microbiological research | HERPESIVIRUS TEST (TYPE L & 2) | March 1, 1977 |