Identity
- Trade Name
- D3 FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control FDA UDI
- Device Name
- DFA HSV TYPING REAGENT DUO PK FDA UDI
- Model / Reference
- 01-090001 FDA UDI
- Description
- DFA HSV TYPING REAGENT DUO PK FDA UDI
Identifiers
- Catalog Number
- 01-090001 FDA UDI
- Primary DI / UDI-DI
- 30014613330714 FDA UDI
- FDA Product Code
- GQN FDA UDI
- GMDN Term
- Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control 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, control
D3 by Diagnostic Hybrids, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control.
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- Herpes Simplex Virus Antigen Control Slide, 4 wells — BION ENTERPRISES, LTD. · Class I
- D3 — DIAGNOSTIC HYBRIDS, INC. · Class II
- D3 — DIAGNOSTIC HYBRIDS, INC. · Class II
- D3 — DIAGNOSTIC HYBRIDS, INC. · Class II
- D3 — DIAGNOSTIC HYBRIDS, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Diagnostic Hybrids, Inc.
Sources (1)
- FDA UDI a9b26aa3-e5ac-4526-be37-33d756b4aa1c 35 fields · synced Jun 6, 2026