Identity
- Trade Name
- Germ Tube Cryo™ FDA UDI
- Generic Name
- Candida albicans microbial identification reagent IVD FDA UDI
- Device Name
- Germ Tube Cryo™, for Candida albicans, 0.5ml, ready to use, 20 vials per package A ready-to-use germ tube solution made up of stabilized animal serum, comes pre-measured in vials. No mixing, measuring, or aliquoting is required! Eliminates exposure to human serum. 0.5ml in each vial. Germ tubes develop on C. albicans within one hour. Serum formula is enhanced for more rapid and luxuriant production of germ tubes. FDA UDI
- Model / Reference
- Z217 FDA UDI
- Description
- Germ Tube Cryo™, for Candida albicans, 0.5ml, ready to use, 20 vials per package A ready-to-use germ tube solution made up of stabilized animal serum, comes pre-measured in vials. No mixing, measuring, or aliquoting is required! Eliminates exposure to human serum. 0.5ml in each vial. Germ tubes develop on C. albicans within one hour. Serum formula is enhanced for more rapid and luxuriant production of germ tubes. FDA UDI
Identifiers
- Catalog Number
- Z217 FDA UDI
- Primary DI / UDI-DI
- 00819398026604 FDA UDI
- FDA Product Code
- JTO FDA UDI
- GMDN Term
- Candida albicans microbial identification reagent IVD 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
No
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 microbial identification reagent IVD
Germ Tube Cryo™ by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Candida albicans microbial identification reagent IVD.
- ACU-NICKERSON — ACUDERM, INC. · 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 45e705fc-c07d-458e-94e8-c84cdd2ca3a6 36 fields · synced May 30, 2026