Rabbit Monoclonal Anti-Human Caldesmon Antibody, EP19

FDA UDI

Class I (US FDA UDI)

by Epitomics, Inc.

Identity

Trade Name: Rabbit Monoclonal Anti-Human Caldesmon Antibody, EP19 FDA UDI
Generic Name: Caldesmon protein IVD, antibody FDA UDI
Device Name: Rabbit Monoclonal Anti-Human Caldesmon (19), concentrated FDA UDI
Model / Reference: AC-0022BULK FDA UDI
Description: Rabbit Monoclonal Anti-Human Caldesmon (19), concentrated FDA UDI

Identifiers

Primary DI / UDI-DI: 00810113060774 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Caldesmon protein 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: Caldesmon protein IVD, antibody

Rabbit Monoclonal Anti-Human Caldesmon Antibody, EP19 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Caldesmon protein IVD, antibody.

Caldesmon (E89) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
h-Caldesmon (hHCD) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
FLEX Mono Mo A-Hu Caldesmon, Cl h-CD, RTU (Dako Omnis) — Agilent Technologies Inc. · Class I
Anti-Caldesmon, HMW — Biogenex Laboratories, Inc. · Class I
h-Caldesmon (hHCD) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
BOND — Leica Biosystems Newcastle, Limited · Class I
CALDESMON HMW, SMOOTH MUSCLE — Biogenex Laboratories, Inc. · Class I
ANTI-CALDESMON — Biogenex Laboratories, 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 6650aea3-2849-41a7-9e01-320760404802 35 fields · synced May 30, 2026