FDA UDI
In Commercial Distribution
🇺🇸 United States
Germ Tube Cryo™
DI: 00819398026604
·
Model: Z217
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Germ Tube Cryo™
- Primary DI
- 00819398026604
- Version / Model
- Z217
- Catalog Number
- Z217
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-08-20
- Public Version
- 1
- Public Version Date
- 2020-08-28
- Public Version Status
- New
- Public Device Record Key
- 45e705fc-c07d-458e-94e8-c84cdd2ca3a6
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62108 | Candida albicans microbial identification reagent IVD | A substance or reactant containing serum, intended to be used in microbial testing to perform a germ tube test for the identification of Candida albicans isolated by culture from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00819398026598 | GS1 | ||||
| Primary | 00819398026604 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – -2 Degrees Celsius