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Anti-EPCAM

FDA UDI

Class I (US FDA UDI)

by Biogenex Laboratories, Inc.

Identity

Trade Name
Anti-EPCAM FDA UDI
Generic Name
Epithelial cell adhesion molecule (EpCAM) IVD, antibody FDA UDI
Model / Reference
AMC16-5M FDA UDI

Identifiers

Catalog Number
AMC16-5M FDA UDI
Primary DI / UDI-DI
00810119672353 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Epithelial cell adhesion molecule (EpCAM) 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

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

Dimensions & Sizes

Size
Total Volume — 6 Milliliter FDA UDI

Category: Epithelial cell adhesion molecule (EpCAM) IVD, antibody

Anti-EPCAM by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Epithelial cell adhesion molecule (EpCAM) IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biogenex Laboratories, Inc.

Sources (1)

  • FDA UDI 00ef2486-acd0-4887-9265-08ca3f980b52 35 fields · synced Jun 1, 2026