Rabbit Monoclonal Anti-Human Calcitonin Antibody, EP92

FDA UDI

Class I (US FDA UDI)

by Epitomics, Inc.

Identity

Trade Name: Rabbit Monoclonal Anti-Human Calcitonin Antibody, EP92 FDA UDI
Generic Name: Calcitonin IVD, antibody FDA UDI
Device Name: Rabbit Monoclonal Anti-Human Calcitonin (92), concentrated FDA UDI
Model / Reference: AC-0092BULK FDA UDI
Description: Rabbit Monoclonal Anti-Human Calcitonin (92), concentrated FDA UDI

Identifiers

Primary DI / UDI-DI: 00810113062990 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Calcitonin 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: Calcitonin IVD, antibody

Rabbit Monoclonal Anti-Human Calcitonin Antibody, EP92 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Calcitonin IVD, antibody.

FLEX Poly Rb A-Hu Calcitonin RTU (Dako Omnis) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
Calcitonin — BIOCARE MEDICAL, LLC · Class I
Calcitonin — BIOCARE MEDICAL, LLC · Class I
IHC — Slmp, LLC · Class I
Calcitonin Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
Calcitonin (SP17) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
BOND™ — Leica Biosystems Newcastle, Limited · Class I
Tinto Calcitonin (RBT-Calcitonin) — BIO SB, 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: Epitomics, Inc.

Sources (1)

FDA UDI f1206da9-6f4b-4742-809a-5a6b72b83659 35 fields · synced May 31, 2026