AlbiQuick™ - AlbiQuick™, for Candida albicans differentiation, - HARDY DIAGNOSTICS

Duns Number:039981550

Device Description: AlbiQuick™, for Candida albicans differentiation, 5 minute test, 25 tests per kitThe new H AlbiQuick™, for Candida albicans differentiation, 5 minute test, 25 tests per kitThe 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) 00819398027298Albiquick Reagent A (1) 00816576029051Developer Reagent (1) 00819398028585

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More Product Details

Catalog Number

Z121

Brand Name

AlbiQuick™

Version/Model Number

Z121

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LIB

Product Code Name

Device, General Purpose, Microbiology, Diagnostic

Device Record Status

Public Device Record Key

b7c0ae8d-10b1-4e1d-b927-a2a45b168395

Public Version Date

August 14, 2020

Public Version Number

1

DI Record Publish Date

August 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HARDY DIAGNOSTICS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 630
2 A medical device with a moderate to high risk that requires special controls. 132