Identity
- Trade Name
- GlabrataQuick™ FDA UDI
- Generic Name
- Candida albicans/C. glabrata antigen IVD, kit, agglutination, rapid FDA UDI
- Device Name
- GlabrataQuick™, for the identification of Candida glabrata, 24 tests GlabrataQuick™, 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) 00819398027595 GlabrataQuick Inoculation Buffer, 1ml (24) 00819398028684 FDA UDI
- Model / Reference
- Z298 FDA UDI
- Description
- GlabrataQuick™, for the identification of Candida glabrata, 24 tests GlabrataQuick™, 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) 00819398027595 GlabrataQuick Inoculation Buffer, 1ml (24) 00819398028684 FDA UDI
Identifiers
- Catalog Number
- Z298 FDA UDI
- Primary DI / UDI-DI
- 00819398028691 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
GlabrataQuick™ by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Candida albicans/C. glabrata antigen IVD, kit, agglutination, rapid.
- AlbiQuick™ — HARDY DIAGNOSTICS · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA UDI 2f94cc80-66c7-4fbb-af95-55d33ce26686 36 fields · synced May 30, 2026