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Cryptococcal Antigen Latex Agglutination System (CALAS)

FDA UDI

Class II (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
Cryptococcal Antigen Latex Agglutination System (CALAS) FDA UDI
Generic Name
Cryptococcus neoformans antigen IVD, kit, rapid agglutination, clinical FDA UDI
Device Name
The Cryptococcal Antigen Latex Agglutination System (CALAS) is a qualitative and semiquantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrospinal fluid (CSF). FDA UDI
Model / Reference
140100 FDA UDI
Description
The Cryptococcal Antigen Latex Agglutination System (CALAS) is a qualitative and semiquantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrospinal fluid (CSF). FDA UDI

Identifiers

Catalog Number
140100 FDA UDI
Primary DI / UDI-DI
00840733101090 FDA UDI
510(k) Number
K894845 FDA UDI
FDA Product Code
GMD FDA UDI
GMDN Term
Cryptococcus neoformans antigen IVD, kit, rapid agglutination, clinical 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, kit, rapid agglutination, clinical

Cryptococcal Antigen Latex Agglutination System (CALAS) 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, kit, rapid agglutination, clinical.

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 ceef24f6-c4f8-4556-ba7e-0e9265dcada1 37 fields · synced May 31, 2026