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Rabbit Monoclonal Anti-Human Helicobacter Pylori Antibody, EP279

FDA UDI

Class I (US FDA UDI)

by Epitomics, Inc.

Identity

Trade Name
Rabbit Monoclonal Anti-Human Helicobacter Pylori Antibody, EP279 FDA UDI
Generic Name
Francisella tularensis total antibody IVD, calibrator FDA UDI
Device Name
Rabbit Monoclonal Anti-Heliobacter Pylori (279), 0.1 mL concentrated FDA UDI
Model / Reference
AC-0247A FDA UDI
Description
Rabbit Monoclonal Anti-Heliobacter Pylori (279), 0.1 mL concentrated FDA UDI

Identifiers

Primary DI / UDI-DI
00810113066592 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Francisella tularensis total antibody IVD, calibrator 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 0.1 Milliliter FDA UDI

Category: Francisella tularensis total antibody IVD, calibrator

Rabbit Monoclonal Anti-Human Helicobacter Pylori Antibody, EP279 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Francisella tularensis total antibody IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epitomics, Inc.

Sources (1)

  • FDA UDI 40ddd48a-be24-40c2-9271-a86d0bcb5181 36 fields · synced May 30, 2026