FDA UDI
Not in Commercial Distribution
🇺🇸 United States
N/A
DI: 00819398027755
·
Model: Z52
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- N/A
- Primary DI
- 00819398027755
- Version / Model
- Z52
- Catalog Number
- Z52
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-06-16
- Public Version
- 2
- Public Version Date
- 2023-04-28
- Public Version Status
- Update
- Public Device Record Key
- 1e4dc7b3-f7cc-4155-b1e9-3902175b227f
- Distribution End Date
- 2023-04-27
Device Description
Hippurate Test, with Ninhydrin, 20 tests per package To be used in the presumptive identification of Gardnerella vaginalis, Campylobacter jejuni, Listeria monocytogenes and group B Streptococcus, by detecting the ability of the organism to hydrolyze hippurate. Total test time is 2.5 hours
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 |
|---|---|---|---|---|
| 43702 | Hippurate hydrolase microbial reagent IVD | A substance or reactant intended to be used in microbial testing to detect the enzyme hippurate hydrolase, produced by a microorganism isolated from a clinical specimen by culture. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00819398027748 | GS1 | ||||
| Primary | 00819398027755 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius