FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00819398027236
·
Model: Z119
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00819398027236
- Version / Model
- Z119
- Catalog Number
- Z119
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-10
- Public Version
- 1
- Public Version Date
- 2020-06-18
- Public Version Status
- New
- Public Device Record Key
- 42b174f0-80ee-49fa-b9e4-ac748bb77df6
Device Description
OxiDrops, liquid oxidase reagent for spot test, 7ml, dropper bottle, by Hardy Diagnostics For testing the oxidase reaction, contains tetramethyl-p-phenylenediamine. Simply place one drop on the suspect colony (directly on the plate) and look for the color reaction. Can also be used on filter paper (cat. no. 28310048). Positives turn purple.
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 |
|---|---|---|---|---|---|---|
| Primary | 00819398027236 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius