Identity
- Trade Name
- Herpes Simplex Virus I RPab FDA UDI
- Generic Name
- Herpes simplex virus 1 (HSV1) antigen IVD, antibody FDA UDI
- Device Name
- Herpes Simplex Virus I is a rabbit polyclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
- Model / Reference
- Concentrate, 1 ml FDA UDI
- Description
- Herpes Simplex Virus I is a rabbit polyclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
Identifiers
- Catalog Number
- BSB 2431 FDA UDI
- Primary DI / UDI-DI
- B502BSB24310 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Herpes simplex virus 1 (HSV1) antigen IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Herpes simplex virus 1 (HSV1) antigen IVD, antibody
Herpes Simplex Virus I RPab by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Herpes simplex virus 1 (HSV1) antigen IVD, antibody.
- HSV I — Biogenex Laboratories, Inc. · Class I
- ANTI-HSV I — Biogenex Laboratories, Inc. · Class I
- ANTI-HERPES SIMPLEX VIRUS TYPE I — Biogenex Laboratories, Inc. · Class I
- IHC — Slmp, LLC · Class I
- IHC — Slmp, LLC · Class I
- Genemed® — Sakura Finetek USA, Inc · Class I
- Tinto Herpes Simplex Virus I — BIO SB, INC. · Class I
- Herpes Simplex Virus I RPab — BIO SB, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Bio Sb, Inc.
Sources (1)
- FDA UDI 6c406c86-2c35-4306-9f90-df0211b8f49a 34 fields · synced May 30, 2026