# K963282: Seraquest HSV Igg

- Pathway: 510(k) (Traditional)
- Applicant: Quest Intl., Inc.
- Decided: Jan 22, 1997 after 154 days
- Product code: LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific)
- Device class: 2
- Regulation: 21 CFR 866.3305
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HSV-1 and HSV-2 Clin-ELISA™ kits, INCSTAR Corporation: named in the summary without a submission number

## Indications for use
For the qualitative and semi-quantitative detection of human IgG antibodies to herpes simplex virus (type 1 or type 2) in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to herpes simplex virus. For manual use, or for use with the HyPrep System Plus. These reagents have not received FDA clearance for use in testing blood or plasma donors.

Source page: https://510kreport.com/device/K963282
Methodology: https://510kreport.com/methodology