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Rabbit Monoclonal Anti-Human TRAcP Antibody, EP338

FDA UDI

Class I (US FDA UDI)

by Epitomics, Inc.

Identity

Trade Name
Rabbit Monoclonal Anti-Human TRAcP Antibody, EP338 FDA UDI
Generic Name
Tartrate resistant acid phosphatase (TRAP) IVD, antibody FDA UDI
Device Name
Rabbit Monoclonal Anti-Human TRAcP (338), 0.1 mL concentrated FDA UDI
Model / Reference
AC-0312A FDA UDI
Description
Rabbit Monoclonal Anti-Human TRAcP (338), 0.1 mL concentrated FDA UDI

Identifiers

Primary DI / UDI-DI
00810113068251 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Tartrate resistant acid phosphatase (TRAP) 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

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 — 0.1 Milliliter FDA UDI

Category: Tartrate resistant acid phosphatase (TRAP) IVD, antibody

Rabbit Monoclonal Anti-Human TRAcP Antibody, EP338 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tartrate resistant acid phosphatase (TRAP) IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epitomics, Inc.

Sources (1)

  • FDA UDI d29d79e5-2252-465f-a3c5-e7bc23f1eb95 36 fields · synced May 31, 2026