← Back to catalogue

00810113069661

FDA UDI

Class I (US FDA UDI)

by Epitomics, Inc.

Identity

Trade Name
00810113069661 FDA UDI
Generic Name
Adrenocorticotropic hormone (ACTH) IVD, antibody FDA UDI
Device Name
Rabbit Monoclonal Anti-Human ACTH (390), concentrated FDA UDI
Model / Reference
AC-0362BULK FDA UDI
Description
Rabbit Monoclonal Anti-Human ACTH (390), concentrated FDA UDI

Identifiers

Primary DI / UDI-DI
00810113069661 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Adrenocorticotropic hormone (ACTH) 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

Category: Adrenocorticotropic hormone (ACTH) IVD, antibody

00810113069661 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Adrenocorticotropic hormone (ACTH) 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 45b3c7c8-f26e-4e0c-82c3-dce6e553551a 35 fields · synced May 30, 2026