Rabbit Monoclonal Anti-Human AFP Antibody, EP209

FDA UDI

Class I (US FDA UDI)

by Epitomics, Inc.

Identity

Trade Name: Rabbit Monoclonal Anti-Human AFP Antibody, EP209 FDA UDI
Generic Name: Alpha-fetoprotein (AFP) IVD, antibody FDA UDI
Device Name: Rabbit Monoclonal Anti-Human AFP (209), concentrated FDA UDI
Model / Reference: AC-0166BULK FDA UDI
Description: Rabbit Monoclonal Anti-Human AFP (209), concentrated FDA UDI

Identifiers

Primary DI / UDI-DI: 00810113064390 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Alpha-fetoprotein (AFP) IVD, antibody

Rabbit Monoclonal Anti-Human AFP Antibody, EP209 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

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BOND™ — Leica Biosystems Newcastle, Limited · Class I
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Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
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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: Epitomics, Inc.

Sources (1)

FDA UDI 983f7ed5-3838-4822-b6d7-23626be91ab5 35 fields · synced Jun 6, 2026