← Back to catalogue

Rabbit Monoclonal Anti-Human GATA3, EP368

FDA UDI

Class I (US FDA UDI)

by Epitomics, Inc.

Identity

Trade Name
Rabbit Monoclonal Anti-Human GATA3, EP368 FDA UDI
Generic Name
GATA protein transcription factor IVD, antibody FDA UDI
Device Name
Rabbit Monoclonal Anti-Human GATA3 (368), 0.1 mL concentrated FDA UDI
Model / Reference
AC-0324A FDA UDI
Description
Rabbit Monoclonal Anti-Human GATA3 (368), 0.1 mL concentrated FDA UDI

Identifiers

Primary DI / UDI-DI
00810113068671 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
GATA protein transcription factor 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 0.1 Milliliter FDA UDI

Category: GATA protein transcription factor IVD, antibody

Rabbit Monoclonal Anti-Human GATA3, EP368 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as GATA protein transcription factor IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Epitomics, Inc.

Sources (1)

  • FDA UDI b97b31fd-7d69-4955-ac45-ed452da79d6e 36 fields · synced May 30, 2026