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Elvis

FDA UDI

Class II (US FDA UDI)

by Diagnostic Hybrids, Inc.

Identity

Trade Name
ELVIS FDA UDI
Generic Name
Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay FDA UDI
Device Name
ELVIS HSV ID/TYPING TEST SYSTEM FDA UDI
Model / Reference
ELVIS HSV ID / D3 Typing Test System FDA UDI
Description
ELVIS HSV ID/TYPING TEST SYSTEM FDA UDI

Identifiers

Catalog Number
SKT-ELVIS-60.V2 FDA UDI
Primary DI / UDI-DI
30014613336334 FDA UDI
FDA Product Code
GQL FDA UDI
GMDN Term
Herpes simplex virus 1 & 2 (HSV1 & 2) antigen 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

Yes

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) antigen IVD, kit, fluorescent immunoassay

Elvis by Diagnostic Hybrids, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnostic Hybrids, Inc.

Sources (1)

  • FDA UDI 3efb7010-bb13-422d-9829-8502a420ec93 35 fields · synced May 30, 2026