HSV-2 Elisa Test System
FDA 510(k) K891782 · Zeus Scientific, Inc.
510(k) numberK891782
Submission
- Device name
- HSV-2 Elisa Test System
- Applicant
- Zeus Scientific, Inc.
Raritan, NJ, US - Received
- March 24, 1989
- Decision date
- June 20, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GQL – Antisera, Fluorescent, Herpesvirus Hominis 1,2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
Other 510(k)s with product code GQL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091753 | Elvis HSV Id and D3 Typing Test SystemGQL · Traditional | Diagnostic Hybrids, Inc. | 08/28/2009SE |
| K081527 | Light Diagnostics HSV 1/2 Typing Dfa KitGQL · Traditional | Millipore Corporation | 04/01/2009SE |
| K984135 | The Aptus (Automated) Application of the HSV-1 Igg Elisa Test System. an Enzyme Linked…GQL · Traditional | Zeus Scientific, Inc. | 05/26/1999SE |
| K984120 | The Aptus(Automated) Application of the HSV-2 Igg Elisa Test System. an Enzyme Linked…GQL · Traditional | Zeus Scientific, Inc. | 05/26/1999SE |
| K905608 | Indirect Fluorescent Assay for Herpes Simplex 1GQL · Traditional | Stellar Bio Systems, Inc. | 11/07/1991SE |
| K904095 | Herpes Simplex Virus Tissue Culture Conf. TypingGQL · Traditional | California Integrated Diagnostics, Inc. | 02/01/1991SE |
| K904167 | Pathodx Herpes TypingGQL · Traditional | Diagnostic Products Corp. | 12/13/1990SE |
| K902662 | Bartels Herpes Simplex Vir Flu Mono Antibody TestGQL · Traditional | Baxter Healthcare Corp | 07/31/1990SE |
| K902661 | Bartels Herpes Simplex Vir Flu Mono Antib HSV-1&2GQL · Traditional | Baxter Healthcare Corp | 07/31/1990SE |
| K891162 | HSV-1 Elisa Test SystemGQL · Traditional | Zeus Scientific, Inc. | 06/20/1989SE |
More from Zeus Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMMOB · Traditional | 08/21/2026SE |
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBOBE · Traditional | 05/08/2026SE |
| K250666 | Alegria Flash CTD ScreenLLL · Traditional | 10/22/2025SE |
| K250408 | Alegria Flash ENA ScreenLLL · Traditional | 09/19/2025SE |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic…MOB · Traditional | 05/07/2025SE |
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFineKTL · Traditional | 08/31/2023SE |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia…LSR · Traditional | 07/13/2023SE |
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFineDHN · Traditional | 04/29/2022SE |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
Questions and answers
When was HSV-2 Elisa Test System cleared by the FDA?
HSV-2 Elisa Test System (K891782) received a 510(k) decision of Substantially Equivalent on June 20, 1989, 88 days after the submission was received.
What is the product code of K891782?
The FDA product code is GQL – Antisera, Fluorescent, Herpesvirus Hominis 1,2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.