Rabbit Monoclonal Anti-Human p27/Kip1 Antibody, EP104

FDA UDI

Class I (US FDA UDI)

by Epitomics, Inc.

Identity

Trade Name: Rabbit Monoclonal Anti-Human p27/Kip1 Antibody, EP104 FDA UDI
Generic Name: p27 antigen IVD, antibody FDA UDI
Device Name: Rabbit Monoclonal Anti-Human p27/Kip1 (104), 1 mL concentrated FDA UDI
Model / Reference: AC-0109 FDA UDI
Description: Rabbit Monoclonal Anti-Human p27/Kip1 (104), 1 mL concentrated FDA UDI

Identifiers

Primary DI / UDI-DI: 00810113063065 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: p27 antigen 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 — 1 Milliliter FDA UDI

Category: p27 antigen IVD, antibody

Rabbit Monoclonal Anti-Human p27/Kip1 Antibody, EP104 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as p27 antigen IVD, antibody.

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P27 KIP1 [Y236] — BIOCARE MEDICAL, LLC · Class I
p27Kip1 (SX53G8) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
p27 KIP1 [Y236] — BIOCARE MEDICAL, LLC · Class I
p27/Kip1 (SX53G8) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
p27Kip1 (SX53G8) 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

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Manufacturer

Manufacturer: Epitomics, Inc.

Sources (1)

FDA UDI 5ec00d12-284f-47a7-8e5d-a724db1b6a6f 36 fields · synced May 30, 2026