Novocastra

FDA UDI

Class I (US FDA UDI)

by Leica Biosystems Newcastle, Limited

Identity

Trade Name: Novocastra FDA UDI
Generic Name: S100-beta (S100-B) protein IVD, antibody FDA UDI
Device Name: NCL-L-S100-167-U is intended for the qualitative identification by light microscopy of S-100B protein in parrafin sections. FDA UDI
Model / Reference: S100-167-L-U FDA UDI
Description: NCL-L-S100-167-U is intended for the qualitative identification by light microscopy of S-100B protein in parrafin sections. FDA UDI

Identifiers

Catalog Number: NCL-L-S100-167-U FDA UDI
Primary DI / UDI-DI: 05055331335760 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: S100-beta (S100-B) 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

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: S100-beta (S100-B) protein 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 S100-beta (S100-B) protein IVD, antibody.

Rabbit Monoclonal Anti-Human S100 beta Antibody, EP32 — EPITOMICS, INC. · Class I
S100Beta RMab — BIO SB, INC. · Class I
Tinto S100 Beta, RMab — BIO SB, INC. · Class I
Anti-S100B Clone - S100B/1012 — Biogenex Laboratories, Inc. · Class I
Rabbit Monoclonal Anti-Human S100 beta Antibody, EP32 — EPITOMICS, INC. · Class I
Tinto S100 Beta, RMab — BIO SB, INC. · Class I
Rabbit Monoclonal Anti-Human S100 beta Antibody, EP32 — EPITOMICS, INC. · Class I
S100Beta RMab — BIO SB, 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: Leica Biosystems Newcastle, Limited

Sources (1)

FDA UDI c195ad05-554a-4250-9e88-c49ddaa47c27 36 fields · synced Jun 1, 2026