Cd34

FDA UDI

Class I (US FDA UDI)

by Biocare Medical, Llc

Identity

Trade Name: CD34 FDA UDI
Generic Name: CD34 cell marker IVD, antibody FDA UDI
Model / Reference: PM084H FDA UDI

Identifiers

Primary DI / UDI-DI: 00847627010933 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: CD34 cell marker 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: CD34 cell marker IVD, antibody

Cd34 by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as CD34 cell marker IVD, antibody.

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CD34 (QBEnd/10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
ANTI-CD34 — Biogenex Laboratories, Inc. · Class I
CD34 (QBEnd/10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
Q-STAIN® QSX-Enh-P CD34 — NOVODIAX, INC. · Class I
IHC — Slmp, LLC · Class I
CD34 (EP88) Rabbit Monoclonal Primary 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

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Manufacturer

Manufacturer: Biocare Medical, Llc

Sources (1)

FDA UDI f45ab90b-a421-4893-9353-9bafccb995e5 33 fields · synced Jun 8, 2026