Rabbit Monoclonal Anti-Human Granzyme B Antibody, EP230

FDA UDI

Class I (US FDA UDI)

by Epitomics, Inc.

Identity

Trade Name: Rabbit Monoclonal Anti-Human Granzyme B Antibody, EP230 FDA UDI
Generic Name: Granzyme B IVD, antibody FDA UDI
Device Name: Rabbit Monoclonal Anti-Human Granzyme B (230), concentrated FDA UDI
Model / Reference: AC-0213CMBULK FDA UDI
Description: Rabbit Monoclonal Anti-Human Granzyme B (230), concentrated FDA UDI

Identifiers

Primary DI / UDI-DI: 00810113065403 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Granzyme B 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

Category: Granzyme B IVD, antibody

Rabbit Monoclonal Anti-Human Granzyme B Antibody, EP230 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Granzyme B IVD, antibody.

Granzyme B (EP230) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
Granzyme B (EP230) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
Tinto Granzyme B RPab — BIO SB, INC. · Class I
Granzyme B Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
Granzyme B RPab — BIO SB, INC. · Class I
Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
Granzyme B (EP230) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
Tissue-Tek Genie® — Sakura Finetek USA, 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

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

Manufacturer

Manufacturer: Epitomics, Inc.

Sources (1)

FDA UDI 84f6614e-70af-489e-bf09-d0e2b792b340 35 fields · synced Jun 8, 2026