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Tinto Herpes Simplex Virus I

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
Tinto Herpes Simplex Virus I 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
Predilute, 15 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 2428 FDA UDI
Primary DI / UDI-DI
B502BSB24280 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Herpes simplex virus 1 (HSV1) antigen IVD, antibody

Tinto Herpes Simplex Virus I 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio Sb, Inc.

Sources (1)

  • FDA UDI ebba137e-9190-490a-9d10-6a432830ed60 34 fields · synced May 30, 2026