GQI — Antiserum, Cf, Cytomegalovirus Class II
FDA Device Classification
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 |
|---|
| K951800 | pyramid biological | CMV IGG HUMAN SERUM CONTROLS | November 16, 1995 |
| K952254 | pyramid biological | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 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 |
| K864420 | diamedix | CMV MICROASSAY | February 2, 1987 |
| K861123 | microbiological research | THE GOLDEN QUAD TEST (CMV) | 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 |