LJB · Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Microbiology · 21 CFR 866.3520 · Class 1
Overview
| Product Code | LJB |
|---|---|
| Device Name | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg |
| Regulation | 21 CFR 866.3520 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974552 | DIAMEDIX IS-MEASLES IGG TEST SYSTEM | Diamedix Corp. | Jan 28, 1998 | SESE |
| K971620 | QUANTA LITE RUBEOLA (MEASLES) IGG | Inova Diagnostics, Inc. | Jul 22, 1997 | SESE |
| K922335 | BARTELS RUBEOLA IGM EIA | Baxter Diagnostics, Inc. | Sep 2, 1992 | SESE |
| K922330 | BARTELS RUBEOLA IGG EIA | Baxter Diagnostics, Inc. | Sep 2, 1992 | SESE |
| K910290 | VIRATEST-DIA(TM) MEASLES (RUBEOLA) | Virus Reference Laboratory, Inc. | Mar 18, 1992 | SESE |
| K904083 | RUBEOLA IGM ELISA TEST | Gull Laboratories, Inc. | Jan 3, 1991 | SESE |
| K903961 | MEASLES IGG MICROASSAY | Diamedix Corp. | Dec 28, 1990 | SESE |
| K904854 | RUBEOLA IGG ELISA TEST | Gull Laboratories, Inc. | Dec 4, 1990 | SESE |
| K891990 | RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 | Clinical Sciences, Inc. | Jun 15, 1989 | SESE |
| K873925 | VIRGO(TM) MEASLES IGG ELISA | Electro-Nucleonics Laboratories, Inc. | Feb 24, 1988 | SESE |
| K821762 | MEASELISA TEST KIT | M.A. Bioproducts | Jul 30, 1982 | SESE |
Top Applicants
- Baxter Diagnostics, Inc. — 2 clearances
- Diamedix Corp. — 2 clearances
- Gull Laboratories, Inc. — 2 clearances
- Clinical Sciences, Inc. — 1 clearance
- Electro-Nucleonics Laboratories, Inc. — 1 clearance
