Antibody Igm,If, Cytomegalovirus Virus
Antibody IgM, IF, Cytomegalovirus Virus is an immunofluorescence assay reagent used to detect IgM-class antibodies specific to cytomegalovirus (CMV), indicating acute or recent primary CMV infection, which is particularly significant in immunocompromised patients and pregnant women. This is an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LKQ, regulated under 21 CFR 866.3175, within the Microbiology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- LKQ
- 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 |
|---|---|---|---|---|
| K100433 | IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, | May 13, 2010 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K972884 | ACCURUN 146 CMV IGM POSITIVE CONTROL | Aug 22, 1997 | Substantially Equivalent | Boston Biomedica, Inc. |
| K933549 | VIDAS CMV IGM ASSAY | Aug 02, 1994 | Substantially Equivalent | Biomerieux Vitek, Inc. |
| K922580 | BARTELS CYTOMEGALOVIRUS IGM EIA | Apr 08, 1993 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K914789 | ELISA CMV IGM | Mar 04, 1992 | Substantially Equivalent | Sclavo, Inc. |
| K913080 | OPUS(R) ANTI CMV-M | Oct 28, 1991 | Substantially Equivalent | Pb Diagnostics, Inc. |
| K900743 | CMV-IGM IFA TEST SYSTEM | Apr 26, 1990 | Substantially Equivalent | Zeus Scientific, Inc. |
| K893465 | CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) | Jul 25, 1989 | Substantially Equivalent | Immuno Concepts, Inc. |
| K893466 | CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) | Jul 14, 1989 | Substantially Equivalent | Immuno Concepts, Inc. |
| K872881 | ABBOTT CMV-M EIA KIT | May 13, 1988 | Substantially Equivalent | Abbott Laboratories |
| K872942 | IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 | Jan 11, 1988 | Substantially Equivalent | Clinical Sciences, Inc. |
| K871832 | CMV IGM MICROASSAY | Aug 07, 1987 | Substantially Equivalent | Diamedix Corp. |
| K863798 | FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES | Apr 14, 1987 | Substantially Equivalent | Whittaker Bioproducts, Inc. |
| K861363 | ENZYGNOST ANTI-CMV IGM TEST | Jul 21, 1986 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K860450 | THE CMV-IGM TEST | May 13, 1986 | Substantially Equivalent | Microbiological Research Corp. |
| K853889 | CORDIA CMV-M | Apr 21, 1986 | Substantially Equivalent | Cordis Corp. |
| K854839 | CYTOMEGELISA M TEST KIT | Feb 04, 1986 | Substantially Equivalent | Whittaker Bioproducts, Inc. |
| K831711 | CMV IGM TEST | Oct 27, 1983 | Substantially Equivalent | Gull Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.