GQI — Antiserum, Cf, Cytomegalovirus Class II
FDA product code GQI covers "Antiserum, Cf, Cytomegalovirus", a Class II medical device regulated under 21 CFR 866.3175. Submissions are reviewed by the Microbiology panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GQI
- Device Class
- Class II
- Regulation Number
- 866.3175
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K952254 | pyramid biological | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | November 16, 1995 |
| K951800 | pyramid biological | CMV IGG HUMAN SERUM CONTROLS | November 16, 1995 |
| K942171 | neogenex | CMV EARLY ANTIGEN TEST | June 30, 1994 |
| K883102 | electro-nucleonics | VIRGO (R) CMV-IGG ELISA | February 8, 1989 |
| K875159 | gull laboratories | DETECTADOT SYSTEM 2000 CMV IGG TEST | May 6, 1988 |
| K863488 | behring diagnostics | ENZYGNOST ANTI-CMV IGG TEST | July 20, 1987 |
| K861123 | microbiological research | THE GOLDEN QUAD TEST (CMV) | February 2, 1987 |
| K864420 | diamedix | CMV MICROASSAY | February 2, 1987 |
| K862705 | labsystems | CYTOMEGALOVIRUS IGG EIA TEST KIT | October 1, 1986 |
| K853989 | cordis | COR DOT CMV | June 13, 1986 |
| K860493 | cytotech | CYTOTECH CMV IGG EIA | May 20, 1986 |
| K854666 | clinical sciences | CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 | February 5, 1986 |
| K843189 | labsystems | CYTOMEGALOVIRUS IGG EIA TEST KIT | January 8, 1986 |
| K842661 | amico lab | ANTI-CYTOMEGALOVIRUS KIT | December 6, 1985 |
| K842529 | amico lab | AMIZYME-CMV KIT | December 6, 1985 |
| K853137 | gull laboratories | CMV TEST | November 14, 1985 |
| K852929 | microbix biosystems | CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR | November 12, 1985 |
| K853277 | hillcrest biologicals | CMV CF ANTIGEN | November 7, 1985 |