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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
Assay development analyte-specific reagent IVD FDA UDI
Device Name
Analyte Specific Reagent. Analytical and performance characteristics are not established. FDA UDI
Model / Reference
B-SARC-L-A FDA UDI
Description
Analyte Specific Reagent. Analytical and performance characteristics are not established. FDA UDI

Identifiers

Catalog Number
NCL-L-b-SARC FDA UDI
Primary DI / UDI-DI
05055331332516 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Assay development analyte-specific reagent IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Assay development analyte-specific reagent IVD

Novocastra™ by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assay development analyte-specific reagent IVD.

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 611ca888-8022-4642-ae5e-0bf80491bac3 36 fields · synced Jun 1, 2026