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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
Coagulation factor XIIIa pro-enzyme subunit IVD, antibody FDA UDI
Device Name
NCL-L-FXIIIa is intended for the qualitative identification by light microscopy of human blood coagulation factor XIIIa in paraffin sections. FDA UDI
Model / Reference
FXIIIA-L-U FDA UDI
Description
NCL-L-FXIIIa is intended for the qualitative identification by light microscopy of human blood coagulation factor XIIIa in paraffin sections. FDA UDI

Identifiers

Catalog Number
NCL-L-FXIIIA FDA UDI
Primary DI / UDI-DI
05055331320827 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Coagulation factor XIIIa pro-enzyme subunit 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: Coagulation factor XIIIa pro-enzyme subunit 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 Coagulation factor XIIIa pro-enzyme subunit 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 919cf3f6-c155-4dfc-8620-d15b1a59b6dc 36 fields · synced May 31, 2026