Rabbit Monoclonal Anti-Human Cytokeratin 13 Antibody, EP69

FDA UDI

Class I (US FDA UDI)

by Epitomics, Inc.

Identity

Trade Name: Rabbit Monoclonal Anti-Human Cytokeratin 13 Antibody, EP69 FDA UDI
Generic Name: Cytokeratin IVD, antibody FDA UDI
Device Name: Rabbit Monoclonal Anti-Human Cytokeratin 13 (69), 0.5 mL concentrated FDA UDI
Model / Reference: AC-0066B FDA UDI
Description: Rabbit Monoclonal Anti-Human Cytokeratin 13 (69), 0.5 mL concentrated FDA UDI

Identifiers

Primary DI / UDI-DI: 00810113062082 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Cytokeratin 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

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 — 0.5 Milliliter FDA UDI

Category: Cytokeratin IVD, antibody

Rabbit Monoclonal Anti-Human Cytokeratin 13 Antibody, EP69 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cytokeratin IVD, antibody.

ANTI-CYTOKERATIN PAN — Biogenex Laboratories, Inc. · Class I
Mouse Monoclonal Anti-Human CK-HMW(MX134) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Cytokeratin 17 RMab — BIO SB, INC. · Class I
Tinto Cytokeratin 7 & CDX2, RMab — BIO SB, INC. · Class I
Cytokeratin 13 RMab — BIO SB, INC. · Class I
Novocastra™ — Leica Biosystems Newcastle, Limited · Class I
Mono Mo A-Hu Cytokeratin 10/13 Cl DE-K13 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
Cytokeratin (CAM 5.2) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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

Manufacturer

Manufacturer: Epitomics, Inc.

Sources (1)

FDA UDI 28266357-1ea0-42cf-a2a2-476ddf06304b 36 fields · synced May 30, 2026