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Hepatitis B Virus Core Antigen Control Slides

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
Hepatitis B Virus Core Antigen Control Slides FDA UDI
Generic Name
Hepatitis B virus core antigen IVD, control FDA UDI
Device Name
Hepatitis B Virus Core Antigen Control Slides FDA UDI
Model / Reference
BSB-9207-CS FDA UDI
Description
Hepatitis B Virus Core Antigen Control Slides FDA UDI

Identifiers

Catalog Number
BSB-9207-CS FDA UDI
Primary DI / UDI-DI
B502BSB9207CS0 FDA UDI
FDA Product Code
LJG FDA UDI
GMDN Term
Hepatitis B virus core antigen IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hepatitis B virus core antigen IVD, control

Hepatitis B Virus Core Antigen Control Slides 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 antigen IVD, control.

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 814afbec-f704-49ca-9fdd-4db40fbff467 36 fields · synced May 30, 2026