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Herpes Simplex Virus Type 2 / HSV-2 IgG IFA Slides Only Kit

FDA UDI

Class II (US FDA UDI)

by Hemagen Diagnostics, Inc.

Identity

Trade Name
Herpes Simplex Virus Type 2 / HSV-2 IgG IFA Slides Only Kit FDA UDI
Generic Name
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
For the detection and titration of HSV-2 IgG antibodies in human sera FDA UDI
Model / Reference
902601 FDA UDI
Description
For the detection and titration of HSV-2 IgG antibodies in human sera FDA UDI

Identifiers

Primary DI / UDI-DI
G5229026011 FDA UDI
510(k) Number
K791058 FDA UDI
FDA Product Code
GQL FDA UDI
GMDN Term
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3305 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Herpes Simplex Virus Type 2 / HSV-2 IgG IFA Slides Only Kit by Hemagen Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.

Cleared under the same submission

K791058 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hemagen Diagnostics, Inc.

Sources (1)

  • FDA UDI 1bfc9585-552f-426a-9080-4c986e482e42 36 fields · synced May 30, 2026