FDA UDI
Not in Commercial Distribution
🇺🇸 United States
N/A
DI: 00819398028592
·
Model: Z120
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00819398028592
- Version / Model
- Z120
- Catalog Number
- Z120
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-06
- Public Version
- 3
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- 77e339f3-11d4-4fb2-9b4f-92bc142bc8b1
- Distribution End Date
- 2023-07-28
Device Description
C. diff PRO, a rapid proline and indole test for Clostridioides difficile, 25 test cards, 1 reagent, 16oz jar C. diff PRO™ Test Kit is recommended for use in screening suspected Clostridioides difficile isolates for L-proline aminopeptidase activity and a lack of indole activity. The test performs a proline separately from indole for a clear test interpretation. Developing Reagent (1) 00819398028585 C. diff PRO Card (25) 00819398027113
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58239 | Chromogenic/colorimetric substrate reagent IVD | A substance or reactant that produces colour in response to a biochemical reaction and intended to be used in combination with other IVDs to test a clinical specimen, typically using an enzyme immunoassay or immunoblot method. Substrate examples include NBT, BCIP, TMB, 4CN, DAB. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819398028592 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius