AlbiQuick™
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…
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
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Jiangxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Zhejiang Runlab Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
Record
| Listed by | Hardy Diagnostics, United States |
|---|---|
| FDA product code | LIB |
| Device type | Device, General Purpose, Microbiology, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-08-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Z121 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 45 |
| Caplugs/Evergreen | Caplugs, Inc. | 28 |
| Device, General Purpose, Microbiology, Diagnostic | Scientific Device Laboratory, Inc. | 21 |
| Globe Scientific | Globe Scientific, LLC | 20 |
| Medline | Medline Industries, Inc. | 15 |
| Parasite Suspensions | Microbiologics, Inc. | 12 |
| Inoculating Loop | Zhejiang Runlab Technology Co., Ltd. | 4 |
| Planet-Safe® | Diversified Biotech, Inc. | 4 |
| Device, General Purpose, Microbiology, Diagnostic | Hardy Diagnostics | 4 |
| Inoculating Loop Typenex | Zhejiang Runlab Technology Co., Ltd. | 4 |
| MicroScan | Beckman Coulter, Inc. | 3 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 2 |
Showing 12 of 64. All products under Device, General Purpose, Microbiology, Diagnostic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.