FDA UDI
In Commercial Distribution
🇺🇸 United States
OxiStrips™
DI: 00819398028721
·
Model: Z93
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- OxiStrips™
- Primary DI
- 00819398028721
- Version / Model
- Z93
- Catalog Number
- Z93
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2020-08-12
- Public Version
- 1
- Public Version Date
- 2020-08-20
- Public Version Status
- New
- Public Device Record Key
- 01c4b340-8c61-4bf8-9673-5d9169f27dc1
Device Description
OxiStrips™, Oxidase test, 25 paper strips per package OxiStrips™ Oxidase Strips are ready to use test strips with a convenient plastic handle so the user can avoid skin contact with the reaction area and are used for the detection of cytochrome oxidase activity in bacteria
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 |
|---|---|---|---|---|
| 38062 | Oxidase production microbial reagent IVD | A substance or reactant, which may be impregnated on a strip or disc, intended to be used in microbial testing to detect the enzyme oxidase, 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 | 00819398027571 | GS1 | ||||
| Primary | 00819398028721 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius