HARDY DIAGNOSTICS

Address:429 S Pioneer Blvd,Springboro,OH,45066,US

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- Catalog Number : Z121

Device Description : AlbiQuick™, for Candida albicans differentiation, 5 minute test, 25 tests per ki 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

Device Class : 1

Duns Number: 039981550

Premarket Exempt : Yes

Product Code : LIB

Prescription Use : No

Device Count : 1

- Catalog Number : Z122

Device Description : StrepQuick™, to aid in the identification of gram positive cocci, performs a PYR StrepQuick™, to aid in the identification of gram positive cocci, performs a PYR, LAP, and Esculin testStrepQuick™ test kit is intended to aid in the identification of gram-positive, catalase-negative cocci based on pyroglutamate aminopeptidase (PYR), leucine aminopeptidase (LAP), and esculin hydrolysis (ESC) activity. This test kit simplifies identification of Enterococcus spp. and group A streptococci (Streptococcus pyogenes)Contains:StrepQuick Test Card (25) 00819398027274Developer Reagent (1) 00819398028585

Device Class : 1

Duns Number: 039981550

Premarket Exempt : Yes

Product Code : LIB

Prescription Use : No

Device Count : 1

- Catalog Number : Z175

Device Description : PYR Test Kit, 100 tests, with 20ml chromogenic developer, on paper disksA rapid PYR Test Kit, 100 tests, with 20ml chromogenic developer, on paper disksA rapid test for Group A Strep and Enterococcus, both of which are PYR positive, all other streps are negative. A more reliable test for Group A Strep than bacitracin, the L-pyrrolidonyl -B-napthylamide impregnated disks serve as a substrate for the detection of pyrrolidonyl peptidase.Contains:PYR Test Disks (100) 00819398027038PYR Test Disk Vial (1) 10819398027035PYR Chromagenic Solution 20mL (1) 00819398028622

Device Class : 1

Duns Number: 039981550

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : No

Device Count : 1

- Catalog Number : Z193

Device Description : OxiSticks™ Oxidase Swabs, 25 swabs per vialFor use in the detection of cytochrom OxiSticks™ Oxidase Swabs, 25 swabs per vialFor use in the detection of cytochrome oxidase activity in bacteria.

Device Class : 1

Duns Number: 039981550

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : No

Device Count : 25

- Catalog Number : Z206

Device Description : CAMP Spot Test Reagent, Beta toxin for Group B Strep (Streptococcus agalactiae) CAMP Spot Test Reagent, Beta toxin for Group B Strep (Streptococcus agalactiae) or Listeria, 1.0ml, CryoVial, 20 per packageA liquid CAMP reagent derived from Staphylococcus hemolysin for the identification of group B Streptococci (Streptococcus agalactiae) or Listeria monocytogenes. Produces enhanced hemolysis. Results can be read in 20 to 60 minutes.

Device Class : 1

Duns Number: 039981550

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : No

Device Count : 20

- Catalog Number : Z275

Device Description : PYR Test Kit, with 15ml chromogenic solution and test cards, 25 cards that have PYR Test Kit, with 15ml chromogenic solution and test cards, 25 cards that have 3 tests per card, total of 75 tests per kitHardy Diagnostics PYR Test Kit and PYR Reagent are recommended for the detection of pyrolidonyl arylamidase (also called pyrolidonyl aminopeptidase) activity in certain groups of bacteria, such as Streptococcus pyogenes (group A strep), Enterococcus spp., some coagulase-negative staphylococci, and some Enterobacteriaceae.The card format is easier to handle than disks. Three tests can be performed on one card.Contains:PYR Test Card (25) 00819398027144PYR Chromagenic Solution 15mL (1) 00819398028660

Device Class : 1

Duns Number: 039981550

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : No

Device Count : 1

- Catalog Number : Z298

Device Description : GlabrataQuick™, for the identification of Candida glabrata, 24 testsGlabrataQuic GlabrataQuick™, for the identification of Candida glabrata, 24 testsGlabrataQuick™, contains two 96 well trays and 24 Inoculation Buffer tubes with 1ml fill to complete a total of 24 tests. GlabrataQuick™ will accurately identify Candida glabrata within one to two hours. It tests for three carbohydrates for greater accuracy; trehalose, sucrose, and maltose. Easy and distinct color read-out. Carbohydrates turn from blue to yellow. A great test to use in conjunction with the HardyCHROM Candida plate (cat. no. G301).Contains: GlabrataQuick Reaction Strips (24) 00819398027595GlabrataQuick Inoculation Buffer, 1ml (24) 00819398028684

Device Class : 1

Duns Number: 039981550

Premarket Exempt : Yes

Product Code : LIB

Prescription Use : No

Device Count : 1

- Catalog Number : Z302

Device Description : Q-Slide™ Gram, a prepared control slide for the QC of the gram stain, has E. col Q-Slide™ Gram, a prepared control slide for the QC of the gram stain, has E. coli and S. aureus, pre-inoculated, 5 slides per boxA convenient ready-to-stain control slide that will test both your stain solutions and your staining techniques. Positive and negative stain control organisms are affixed to the circles in each Q-Slide™. Up to four patient specimens (in the squares) may be processed at the same time as the QC organisms.

Device Class : 1

Duns Number: 039981550

Premarket Exempt : Yes

Product Code : LJG

Prescription Use : No

Device Count : 5

- Catalog Number : Z51

Device Description : Beta Lactamase Test, acidometric method, 20 tests per packageAn rapid acidometri Beta Lactamase Test, acidometric method, 20 tests per packageAn rapid acidometric method for performing a beta-lactamase test on Haemophilus spp., S. aureus, and N. gonorrhoeae. Easy to read, clear cut color change, just add bacteria and water to tube. Not for use with anaerobes.

Device Class : 1

Duns Number: 039981550

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : No

Device Count : 20

- Catalog Number : Z93

Device Description : OxiStrips™, Oxidase test, 25 paper strips per packageOxiStrips™ Oxidase Strips a OxiStrips™, Oxidase test, 25 paper strips per packageOxiStrips™ Oxidase Strips are ready to use test strips with a convenient plastic handle so the user can avoid skin contact with the reaction area and are used for the detection of cytochrome oxidase activity in bacteria

Device Class : 1

Duns Number: 039981550

Premarket Exempt : Yes

Product Code : JTO

Prescription Use : No

Device Count : 25