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PREMIER Cryptococcal Antigen

FDA UDI

Class II (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
PREMIER Cryptococcal Antigen FDA UDI
Generic Name
Cryptococcus neoformans antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The PREMIERCryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrospinal fluid (CSF). FDA UDI
Model / Reference
602096 FDA UDI
Description
The PREMIERCryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrospinal fluid (CSF). FDA UDI

Identifiers

Catalog Number
602096 FDA UDI
Primary DI / UDI-DI
00840733101229 FDA UDI
FDA Product Code
MDU FDA UDI
GMDN Term
Cryptococcus neoformans antigen IVD, kit, enzyme immunoassay (EIA) 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, enzyme immunoassay (EIA)

A comprehensive enzyme immunoassay for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrospinal fluid, available as a single-use test kit.

Similar devices

Also classified as Cryptococcus neoformans antigen IVD, kit, enzyme immunoassay (EIA).

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 5599aff4-55cd-4f7f-8230-498a20d07ee7 36 fields · synced Jul 7, 2026