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Novocastra™

FDA UDI

Class I (US FDA UDI)

by Leica Biosystems Newcastle, Limited

Identity

Trade Name
Novocastra™ FDA UDI
Generic Name
Tartrate resistant acid phosphatase (TRAP) IVD, antibody FDA UDI
Device Name
NCL-L-TRAP is intended for the qualitative identification by light microscopy of human tartrate-resistant acid phosphatase (TRAP) protein in paraffin sections. FDA UDI
Model / Reference
TRAP-L-U FDA UDI
Description
NCL-L-TRAP is intended for the qualitative identification by light microscopy of human tartrate-resistant acid phosphatase (TRAP) protein in paraffin sections. FDA UDI

Identifiers

Catalog Number
NCL-L-TRAP FDA UDI
Primary DI / UDI-DI
05055331320865 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

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Novocastra™ by Leica Biosystems Newcastle, Limited — 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
Leica Biosystems Newcastle, Limited

Sources (1)

  • FDA UDI 0436d0bc-2f0a-4a37-ae61-30f4f6131567 36 fields · synced May 30, 2026