Ae1/Ae3 + 8/18

FDA UDI

Class I (US FDA UDI)

by Biocare Medical, Llc

Identity

Trade Name: AE1/AE3 + 8/18 FDA UDI
Generic Name: Cytokeratin IVD, antibody FDA UDI
Device Name: Alternate name : Pan Cytokeratin Plus [AE1/AE3+8/18] FDA UDI
Model / Reference: CM162B FDA UDI
Description: Alternate name : Pan Cytokeratin Plus [AE1/AE3+8/18] FDA UDI

Identifiers

Primary DI / UDI-DI: 00847627006530 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

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cytokeratin IVD, antibody

Ae1/Ae3 + 8/18 by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Cytokeratin IVD, antibody.

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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
Rabbit Monoclonal Anti-Human Cytokeratin 19 Antibody, EP72 — EPITOMICS, INC. · 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

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Manufacturer

Manufacturer: Biocare Medical, Llc

Sources (1)

FDA UDI d50a2ee8-6f49-46a2-a583-b1f75117848a 34 fields · synced Jun 1, 2026