Alpha-Fetoprotein RMab

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name: Alpha-Fetoprotein RMab FDA UDI
Generic Name: Alpha-fetoprotein (AFP) IVD, antibody FDA UDI
Device Name: Alpha-Fetoprotein is a rabbit 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, 0.1 ml FDA UDI
Description: Alpha-Fetoprotein is a rabbit 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 2387 FDA UDI
Primary DI / UDI-DI: B502BSB23870 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Alpha-fetoprotein (AFP) IVD, antibody FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.1860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Alpha-fetoprotein (AFP) IVD, antibody

Alpha-Fetoprotein RMab by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alpha-fetoprotein (AFP) IVD, antibody.

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FLEX Poly Rb A-Hu Alpha-1-Fetoprotein RTU (Dako Omnis) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
FLEX Poly Rb A-Hu Alpha-1-Fetoprotein RTU (Link) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
BOND™ — Leica Biosystems Newcastle, Limited · Class I
IHC — Slmp, LLC · Class I
Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
Genemed® — Sakura Finetek USA, Inc · Class I
BOND™ — Leica Biosystems Newcastle, Limited · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Bio Sb, Inc.

Sources (1)

FDA UDI c34a3276-243c-44c2-94e5-7ef13b3fefd2 34 fields · synced Jun 8, 2026