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AlbiQuick™

FDA UDI

Class I (US FDA UDI)

by Hardy Diagnostics

Identity

Trade Name
AlbiQuick™ FDA UDI
Generic Name
Candida albicans/C. glabrata antigen IVD, kit, agglutination, rapid FDA UDI
Device Name
AlbiQuick™, for Candida albicans differentiation, 5 minute test, 25 tests per kit The new Hardy AlbiQuick™ utilizes two enzyme color reactions to produce an accurate result that’s easy to read out. AlbiQuick is performed on a convenient card with two reaction wells. Only Candida albicans possesses the enzymes that will hydrolyze the PRO and NAG compounds on the card. Incubation time is only five minutes at room temperature! Requires the use of a handheld 366nm ultra violet lamp(see Cat. no. UVL56). The old germ tube method of C. albicans identification requires several hours of incubation and tedious microscopy to produce a result. The AlbiQuick™ eliminates the need for this and other lengthy procedures. A recent study, which compared the above NAG and PRO methods to the traditional germ tube test, showed a sensitivity of 99% and a specificity of 99-100% (the germ tube test showed a sensitivity of 95% and a specificity of 99%; all isolates confirmed by API 20C). Ref: Crist, et al, J. Clin. Microbiol. 34:2616-2618. Accurate, fast, and convenient...that’s AlbiQuick™! Contains: Albiquick Test Cards (25) 00819398027298 Albiquick Reagent A (1) 00816576029051 Developer Reagent (1) 00819398028585 FDA UDI
Model / Reference
Z121 FDA UDI
Description
AlbiQuick™, for Candida albicans differentiation, 5 minute test, 25 tests per kit The new Hardy AlbiQuick™ utilizes two enzyme color reactions to produce an accurate result that’s easy to read out. AlbiQuick is performed on a convenient card with two reaction wells. Only Candida albicans possesses the enzymes that will hydrolyze the PRO and NAG compounds on the card. Incubation time is only five minutes at room temperature! Requires the use of a handheld 366nm ultra violet lamp(see Cat. no. UVL56). The old germ tube method of C. albicans identification requires several hours of incubation and tedious microscopy to produce a result. The AlbiQuick™ eliminates the need for this and other lengthy procedures. A recent study, which compared the above NAG and PRO methods to the traditional germ tube test, showed a sensitivity of 99% and a specificity of 99-100% (the germ tube test showed a sensitivity of 95% and a specificity of 99%; all isolates confirmed by API 20C). Ref: Crist, et al, J. Clin. Microbiol. 34:2616-2618. Accurate, fast, and convenient...that’s AlbiQuick™! Contains: Albiquick Test Cards (25) 00819398027298 Albiquick Reagent A (1) 00816576029051 Developer Reagent (1) 00819398028585 FDA UDI

Identifiers

Catalog Number
Z121 FDA UDI
Primary DI / UDI-DI
00819398028608 FDA UDI
FDA Product Code
LIB FDA UDI
GMDN Term
Candida albicans/C. glabrata antigen IVD, kit, agglutination, rapid FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Candida albicans/C. glabrata antigen IVD, kit, agglutination, rapid

AlbiQuick™ by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Candida albicans/C. glabrata antigen IVD, kit, agglutination, rapid.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hardy Diagnostics

Sources (1)

  • FDA UDI b7c0ae8d-10b1-4e1d-b927-a2a45b168395 36 fields · synced Jun 6, 2026