Antiserum, Cf, Cytomegalovirus
The Antiserum, CF, Cytomegalovirus is a complement fixation antiserum used as a laboratory reagent to aid in the serological detection of cytomegalovirus (CMV) infection. It carries an FDA Class 2 designation, meaning it presents moderate risk and requires a 510(k) premarket notification prior to marketing. The product code is GQI, regulated under 21 CFR 866.3175 within the Microbiology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- GQI
- Device Class
- FDA class 2
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K952254 | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | Nov 16, 1995 | Substantially Equivalent | Pyramid Biological Corp. |
| K951800 | CMV IGG HUMAN SERUM CONTROLS | Nov 16, 1995 | Substantially Equivalent | Pyramid Biological Corp. |
| K942171 | CMV EARLY ANTIGEN TEST | Jun 30, 1994 | Substantially Equivalent | Neogenex |
| K883102 | VIRGO (R) CMV-IGG ELISA | Feb 08, 1989 | Substantially Equivalent | Electro-Nucleonics, Inc. |
| K875159 | DETECTADOT SYSTEM 2000 CMV IGG TEST | May 06, 1988 | Substantially Equivalent | Gull Laboratories, Inc. |
| K863488 | ENZYGNOST ANTI-CMV IGG TEST | Jul 20, 1987 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K864420 | CMV MICROASSAY | Feb 02, 1987 | Substantially Equivalent | Diamedix Corp. |
| K861123 | THE GOLDEN QUAD TEST (CMV) | Feb 02, 1987 | Substantially Equivalent | Microbiological Research Corp. |
| K862705 | CYTOMEGALOVIRUS IGG EIA TEST KIT | Oct 01, 1986 | Substantially Equivalent | Labsystems, Inc. |
| K853989 | COR DOT CMV | Jun 13, 1986 | Substantially Equivalent | Cordis Corp. |
| K860493 | CYTOTECH CMV IGG EIA | May 20, 1986 | Substantially Equivalent | Cytotech, Inc. |
| K854666 | CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 | Feb 05, 1986 | Substantially Equivalent | Clinical Sciences, Inc. |
| K843189 | CYTOMEGALOVIRUS IGG EIA TEST KIT | Jan 08, 1986 | Substantially Equivalent | Labsystems, Inc. |
| K842661 | ANTI-CYTOMEGALOVIRUS KIT | Dec 06, 1985 | Substantially Equivalent | Amico Lab, Inc. |
| K842529 | AMIZYME-CMV KIT | Dec 06, 1985 | Substantially Equivalent | Amico Lab, Inc. |
| K853137 | CMV TEST | Nov 14, 1985 | Substantially Equivalent | Gull Laboratories, Inc. |
| K852929 | CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR | Nov 12, 1985 | Substantially Equivalent | Microbix Biosystems, Inc. |
| K853277 | CMV CF ANTIGEN | Nov 07, 1985 | Substantially Equivalent | Hillcrest Biologicals |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.