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CALAS Pronase

FDA UDI

Class II (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
CALAS Pronase FDA UDI
Generic Name
Cryptococcus neoformans antigen IVD, reagent FDA UDI
Device Name
CALAS Pronase is a serum pretreatment reagent for use with Cryptococcal Antigen Latex Agglutination System (CALAS). FDA UDI
Model / Reference
140050 FDA UDI
Description
CALAS Pronase is a serum pretreatment reagent for use with Cryptococcal Antigen Latex Agglutination System (CALAS). FDA UDI

Identifiers

Catalog Number
140050 FDA UDI
Primary DI / UDI-DI
00840733101083 FDA UDI
510(k) Number
K894845 FDA UDI
FDA Product Code
GMD FDA UDI
GMDN Term
Cryptococcus neoformans antigen IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3165 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cryptococcus neoformans antigen IVD, reagent

CALAS Pronase by Meridian Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cryptococcus neoformans antigen IVD, reagent.

Cleared under the same submission

K894845 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meridian Bioscience, Inc.

Sources (1)

  • FDA UDI 440d07ec-8c1a-4c82-8ec8-010f539a339b 37 fields · synced May 29, 2026