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Mono Mo A-Hu Epithelial Antigen Cl Ber-EP4

FDA UDI

Class I (US FDA UDI)

by Agilent Technologies Singapore Pte Ltd

Identity

Trade Name
Mono Mo A-Hu Epithelial Antigen Cl Ber-EP4 FDA UDI
Generic Name
Epithelial antigen IVD, antibody FDA UDI
Device Name
Monoclonal Mouse Anti-Human Epithelial Antigen Clone Ber-EP4 FDA UDI
Model / Reference
M0804 FDA UDI
Description
Monoclonal Mouse Anti-Human Epithelial Antigen Clone Ber-EP4 FDA UDI

Identifiers

Primary DI / UDI-DI
05700572005629 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Epithelial antigen 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 — 1 Milliliter FDA UDI

Category: Epithelial antigen IVD, antibody

Mono Mo A-Hu Epithelial Antigen Cl Ber-EP4 by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Epithelial antigen IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Agilent Technologies Singapore Pte Ltd

Sources (1)

  • FDA UDI 878d5913-372e-494e-8a72-2c4ded429fb5 36 fields · synced May 30, 2026