FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 00816576020225
·
Model: J112
·
HARDY DIAGNOSTICS
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- NA
- Primary DI
- 00816576020225
- Version / Model
- J112
- Catalog Number
- J112
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 3
- Public Version Date
- 2020-06-18
- Public Version Status
- Update
- Public Device Record Key
- 304cb67d-28e0-4524-8e90-a2e5dc7babc0
- Distribution End Date
- 2020-06-17
Device Description
MRSA / VRE BIPLATE (Sect. 1: MH with 4% NaCl and Oxacillin 6mcg/ml; Sect II: BHI Agar with Vancomycin 6mcg/ml). For the detection of Methicillin Resistant Staphylococcus aureus and Vancomycin Resistant Enterococci.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | Microbiology | 866.1700 | 2 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | Microbiology | 866.1700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62106 | Multiple formulation agar culture medium IVD | A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816576020225 | GS1 | ||||
| Unit of Use | 00816576021307 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius