AlbiQuick™
- Primary DI
- 00819398028608
- Brand
- AlbiQuick™
- Company
- HARDY DIAGNOSTICS
- Model
- Z121
- Catalog number
- Z121
- Device 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
- Published
- 2020-08-06
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic | Microbiology | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00819398028608 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00819398028608 | 00819398028608 | 819398028608 | 0819398028608 |
GMDN Terms#
| Term | Definition |
|---|---|
| Candida albicans/C. glabrata antigen IVD, kit, agglutination, rapid | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from the yeast species Candida albicans and/or Candida glabrata in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an agglutination method. This test is commonly used in the laboratory or in point-of-care analyses. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 800-266-2222 | techservice@hardydiagnostics.com |
Regulatory Flags#
- DUNS number
- 039981550
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00816576027958 | N/A | W95 | W95 | 2020-06-08 |
| 00819398024594 | N/A | Y100 | Y100 | 2020-06-08 |
| 00819398023603 | N/A | R76BX | R76BX | 2020-06-05 |
| 00819398024235 | HardyFlask™ | X26 | X26 | 2020-06-08 |
| 00816576027088 | HardyDisk™ | Z9491 | Z9491 | 2025-08-08 |
| 00816576026975 | HardyDisk™ | Z9485 | Z9485 | 2025-07-14 |
| 00816576027439 | QwikID | IG06020C03 | IG06020C03 | 2025-06-23 |
| 00819398027199 | N/A | Z134 | Z134 | 2020-06-10 |
| 00819398027779 | N/A | Z135 | Z135 | 2020-06-10 |
| 00816576023516 | N/A | 1020 | 1020 | 2020-05-26 |
| 00816576025800 | TransPRO | TPV50 | TPV50 | 2024-10-08 |
| 00816576026951 | N/A | G367 | G367 | 2024-07-08 |
| 00816576026586 | N/A | J139 | J139 | 2020-05-20 |
| 00816576026876 | N/A | R12 | R12 | 2024-03-08 |
| 00819398021593 | N/A | R63BX | R63BX | 2024-01-15 |
| 00819398020602 | N/A | K02 | K02 | 2020-05-24 |
| 00816576026838 | HardyCHROM™ | J28 | J28 | 2023-12-08 |
| 00816576024391 | AnaeroGRO | AG051 | AG051 | 2020-05-12 |
| 00819398020725 | HardyDisk™ | Z9465 | Z9465 | 2023-11-21 |
| 00819398023627 | N/A | R80 | R80 | 2020-06-05 |
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