Antigen, Iha, Cytomegalovirus
Antigen, IHA, Cytomegalovirus is an antigen reagent used in indirect hemagglutination (IHA) assays to detect antibodies against cytomegalovirus (CMV), a common herpesvirus that can cause serious disease in immunocompromised patients and newborns. It is an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LJO, 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
- LJO
- 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 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K203612 | Capture-CMV | Mar 22, 2021 | Substantially Equivalent | Immucor, Inc. |
| K183571 | Capture-CMV | Feb 04, 2019 | Substantially Equivalent | Immucor, Inc. |
| K001767 | DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM | Aug 07, 2000 | Substantially Equivalent | Diamedix Corp. |
| K974901 | HYBRID CAPTURE SYSTEM CMV DNA ASSAY | Sep 29, 1998 | Substantially Equivalent | Digene Corp. |
| K974456 | CMVGEN | May 01, 1998 | Substantially Equivalent | Instrumentation Laboratory CO |
| K951851 | ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY | Jul 24, 1996 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K955799 | COPALIS CMV TOTAL ANTIBODY ASSAY | Jul 10, 1996 | Substantially Equivalent | Sienna Biotech, Inc. |
| K920222 | HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS | Jul 27, 1992 | Substantially Equivalent | Akers Research Corp. |
| K910003 | CYTOMEGALOVIRUS ANTIBODY SCREEN | Mar 20, 1991 | Substantially Equivalent | Immucor, Inc. |
| K852494 | CMV-IHA | Sep 16, 1985 | Substantially Equivalent | Hillcrest Biologicals |
| K841520 | CMV LATEX AGGLUTINATION TEST KIT | Sep 07, 1984 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K822965 | CETUS CMV IHA | Feb 15, 1983 | Substantially Equivalent | Cetus Corp. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.