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Tinto Hepatitis B Virus Core Antigen, RPab

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
Tinto Hepatitis B Virus Core Antigen, RPab FDA UDI
Generic Name
Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent FDA UDI
Device Name
Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6 FDA UDI
Model / Reference
Predilute, 3 ml FDA UDI
Description
Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6 FDA UDI

Identifiers

Catalog Number
BSB 5610 FDA UDI
Primary DI / UDI-DI
B502BSB56100 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent 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 core immunoglobulin G (IgG) antibody IVD, reagent

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

Similar devices

Also classified as Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent.

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 ed1ca4e8-c095-47e8-8541-a373a41a2c33 34 fields · synced May 30, 2026