FDA UDI
In Commercial Distribution
🇺🇸 United States
HardyDisk™
DI: 00819398028578
·
Model: Z118
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- HardyDisk™
- Primary DI
- 00819398028578
- Version / Model
- Z118
- Catalog Number
- Z118
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2020-07-09
- Public Version
- 2
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- 9d6199e6-6ada-4d77-919a-ae907289a20d
Device Description
Caffeic Acid Disks, for Cryptococcus, 25 disks per pack HardyDisk™ Caffeic Acid Disks detect the ability of an organism to produce the enzyme phenyloxidase, which is useful for the identification of Cryptococcus neoformans and Cryptococcus gattii.
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 |
|---|---|---|---|---|
| 61044 | Multiple-type meningitis pathogen nucleic acid IVD, reagent | A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay intended to be used for the qualitative and/or quantitative detection nucleic acid from multiple types of microorganisms associated with meningitis, in a clinical specimen. Microorganisms detected may include but are not limited to Streptococcus meningitidis, Neisseria meningitidis, Haemophilus influenzae, Cryptococcus neoformans, adenovirus, enterovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2), varicella-zoster virus (VZV), and Mumps virus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00819398027557 | GS1 | ||||
| Primary | 00819398028578 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius