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Hepatitis B Virus Surface Antigen (S1-210) Mouse Monoclonal Antibody

FDA UDI

Class I (US FDA UDI)

by Cell Marque Corporation

Identity

Trade Name
Hepatitis B Virus Surface Antigen (S1-210) Mouse Monoclonal Antibody FDA UDI
Generic Name
Assay development analyte-specific reagent IVD FDA UDI
Model / Reference
217M-17-ASR FDA UDI

Identifiers

Primary DI / UDI-DI
00841683127499 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Assay development analyte-specific reagent IVD 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Assay development analyte-specific reagent IVD

This Hepatitis B Virus Surface Antigen (S1-210) Mouse Monoclonal Antibody device is a laboratory developed test (LDT) used for the development of an analyte-specific reagent (ASR), which is neither labelled with instructions for use nor diagnostic or performance claims. It is a combination product, has been published since 2022-11-14, and is marketed by CELL MARQUE CORPORATION.

Similar devices

Also classified as Assay development analyte-specific reagent IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cell Marque Corporation

Sources (1)

  • FDA UDI af2b4ca2-cc65-4a26-89e3-e7a3a72825b2 33 fields · synced Jul 13, 2026