LJB — Enzyme Linked Immunoabsorbent Assay, Rubeola Igg Class I
Classification Details
- Product Code
- LJB
- Device Class
- Class I
- Regulation Number
- 866.3520
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
The qualitative detection of measles specific IgG antibodies in serum or plasma.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K974552 | diamedix | DIAMEDIX IS-MEASLES IGG TEST SYSTEM | January 28, 1998 |
| K971620 | inova diagnostics | QUANTA LITE RUBEOLA (MEASLES) IGG | July 22, 1997 |
| K922330 | baxter diagnostics | BARTELS RUBEOLA IGG EIA | September 2, 1992 |
| K922335 | baxter diagnostics | BARTELS RUBEOLA IGM EIA | September 2, 1992 |
| K910290 | virus reference laboratory | VIRATEST-DIA(TM) MEASLES (RUBEOLA) | March 18, 1992 |
| K904083 | gull laboratories | RUBEOLA IGM ELISA TEST | January 3, 1991 |
| K903961 | diamedix | MEASLES IGG MICROASSAY | December 28, 1990 |
| K904854 | gull laboratories | RUBEOLA IGG ELISA TEST | December 4, 1990 |
| K891990 | clinical sciences | RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 | June 15, 1989 |
| K873925 | electro-nucleonics laboratories | VIRGO(TM) MEASLES IGG ELISA | February 24, 1988 |
| K821762 | m.a. bioproducts | MEASELISA TEST KIT | July 30, 1982 |