← Back to catalogue

Novocastra™

FDA UDI

Class I (US FDA UDI)

by Leica Biosystems Newcastle, Limited

Identity

Trade Name
Novocastra™ FDA UDI
Generic Name
Mast cell protease IVD, antibody FDA UDI
Device Name
NCL-L-MCTRYP-428 is intended for the qualitative identification by light microscopy of human mast cell tryptase in paraffin sections. FDA UDI
Model / Reference
MCTRYP-428-L-U FDA UDI
Description
NCL-L-MCTRYP-428 is intended for the qualitative identification by light microscopy of human mast cell tryptase in paraffin sections. FDA UDI

Identifiers

Catalog Number
NCL-L-MCTRYP-428 FDA UDI
Primary DI / UDI-DI
05055331321220 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Mast cell protease 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: Mast cell protease 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 Mast cell protease IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Leica Biosystems Newcastle, Limited

Sources (1)

  • FDA UDI 80b72879-13a6-42e3-942d-08f33a58f71a 36 fields · synced May 30, 2026