Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
An enzyme-linked immunosorbent assay (ELISA) for rubeola IgG is a laboratory diagnostic test intended for the qualitative detection of measles-specific IgG antibodies in serum or plasma, used to assess immunity to measles following vaccination or natural infection. The device is FDA Class 1, the lowest risk category, subject only to general controls and exempt from premarket notification requirements. It carries product code LJB and is regulated under 21 CFR 866.3520 within the Microbiology specialty. No special flags apply to this device.
Basic Information
- Product Code
- LJB
- Device Class
- FDA class 1
- Regulation Number
- 866.3520
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
Definition
The qualitative detection of measles specific IgG antibodies in serum or plasma.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K974552 | DIAMEDIX IS-MEASLES IGG TEST SYSTEM | Jan 28, 1998 | Substantially Equivalent | Diamedix Corp. |
| K971620 | QUANTA LITE RUBEOLA (MEASLES) IGG | Jul 22, 1997 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K922335 | BARTELS RUBEOLA IGM EIA | Sep 02, 1992 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K922330 | BARTELS RUBEOLA IGG EIA | Sep 02, 1992 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K910290 | VIRATEST-DIA(TM) MEASLES (RUBEOLA) | Mar 18, 1992 | Substantially Equivalent | Virus Reference Laboratory, Inc. |
| K904083 | RUBEOLA IGM ELISA TEST | Jan 03, 1991 | Substantially Equivalent | Gull Laboratories, Inc. |
| K903961 | MEASLES IGG MICROASSAY | Dec 28, 1990 | Substantially Equivalent | Diamedix Corp. |
| K904854 | RUBEOLA IGG ELISA TEST | Dec 04, 1990 | Substantially Equivalent | Gull Laboratories, Inc. |
| K891990 | RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 | Jun 15, 1989 | Substantially Equivalent | Clinical Sciences, Inc. |
| K873925 | VIRGO(TM) MEASLES IGG ELISA | Feb 24, 1988 | Substantially Equivalent | Electro-Nucleonics Laboratories, Inc. |
| K821762 | MEASELISA TEST KIT | Jul 30, 1982 | Substantially Equivalent | M.A. Bioproducts |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.