Quanta Lite Rubeola (Measles) Igg
FDA 510(k) K971620 · Inova Diagnostics, Inc.
510(k) numberK971620
Submission
- Device name
- Quanta Lite Rubeola (Measles) Igg
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- May 1, 1997
- Decision date
- July 22, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LJB – Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3520
- Specialty
- Microbiology
The qualitative detection of measles specific IgG antibodies in serum or plasma.
Other 510(k)s with product code LJB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974552 | Diamedix Is-Measles Igg Test SystemLJB · Traditional | Diamedix Corp. | 01/28/1998SE |
| K922335 | Bartels Rubeola Igm EiaLJB · Traditional | Baxter Diagnostics, Inc. | 09/02/1992SE |
| K922330 | Bartels Rubeola Igg EiaLJB · Traditional | Baxter Diagnostics, Inc. | 09/02/1992SE |
| K910290 | Viratest-Dia(Tm) Measles (Rubeola)LJB · Traditional | Virus Reference Laboratory, Inc. | 03/18/1992SE |
| K904083 | Rubeola Igm Elisa TestLJB · Traditional | Gull Laboratories, Inc. | 01/03/1991SE |
| K903961 | Measles Igg MicroassayLJB · Traditional | Diamedix Corp. | 12/28/1990SE |
| K904854 | Rubeola Igg Elisa TestLJB · Traditional | Gull Laboratories, Inc. | 12/04/1990SE |
| K891990 | Rubeola Igg Clin-Elisa Test System, Cat. #4600LJB · Traditional | Clinical Sciences, Inc. | 06/15/1989SE |
| K873925 | Virgo(Tm) Measles Igg ElisaLJB · Traditional | Electro-Nucleonics Laboratories, Inc. | 02/24/1988SE |
| K821762 | Measelisa Test KitLJB · Traditional | M.A. Bioproducts | 07/30/1982SE |
More from M.A. Bioproducts
| 510(k) | Device | Decision |
|---|---|---|
| K243979 | Aptiva APS IgA ReagentMSV · Traditional | 02/06/2026SE |
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM ReagentMID · Traditional | 12/17/2024SE |
| K213403 | Aptiva CTD Essential ReagentLLL · Traditional | 09/29/2023SE |
| K200230 | Aptiva Celiac Disease IgG ReagentMVM · Traditional | 08/26/2021SE |
| K193604 | Aptiva Celiac Disease IgA ReagentMVM · Traditional | 06/16/2021SE |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae KitKTL · Traditional | 12/11/2020SE |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR · Traditional | 04/17/2019SE |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO · Traditional | 10/16/2018SE |
| K180975 | QUANTA Flash HMGCR ReagentsLLL · Traditional | 06/25/2018SE |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash…NXO · Traditional | 12/22/2017SE |
Questions and answers
When was Quanta Lite Rubeola (Measles) Igg cleared by the FDA?
Quanta Lite Rubeola (Measles) Igg (K971620) received a 510(k) decision of Substantially Equivalent on July 22, 1997, 82 days after the submission was received.
What is the product code of K971620?
The FDA product code is LJB – Enzyme Linked Immunoabsorbent Assay, Rubeola Igg, a Class I (low risk) device regulated under 21 CFR 866.3520.