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Hepatitis B Virus Surface Antigen MMab

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
Hepatitis B Virus Surface Antigen MMab FDA UDI
Generic Name
Hepatitis B virus surface antigen IVD, antibody FDA UDI
Device Name
HBsAg is a mouse monoclonal 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
HBsAg is a mouse monoclonal 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 5622 FDA UDI
Primary DI / UDI-DI
B502BSB56220 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Hepatitis B virus surface 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
MRI Safety
MR Safe FDA UDI

Category: Hepatitis B virus surface antigen IVD, antibody

Hepatitis B Virus Surface Antigen MMab by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hepatitis B virus surface 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 c6b3c2a0-5401-4c39-b551-7cf93d3ad54a 34 fields · synced May 30, 2026