FDA UDI
Not in Commercial Distribution
🇺🇸 United States
N/A
DI: 00816576026654
·
Model: J181
·
HARDY DIAGNOSTICS
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- N/A
- Primary DI
- 00816576026654
- Version / Model
- J181
- Catalog Number
- J181
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-05-20
- Public Version
- 2
- Public Version Date
- 2022-04-01
- Public Version Status
- Update
- Public Device Record Key
- d9e19025-1d33-403e-b6f5-f26e20b1d4f1
- Distribution End Date
- 2022-03-31
Device Description
V Agar / Starch Agar with Bromcresol Purple, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Starch Agar with Bromcresol Purple is recommended for use in the differentiation of Gardnerella vaginalis from genitourinary specimens. Hardy Diagnostics V Agar is an enriched media used for the isolation and differentiation of Gardnerella vaginalis.
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 |
|---|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-Differential | Microbiology | 866.2300 | 1 |
| KZI | Culture Media, Enriched | Microbiology | 866.2330 | 1 |
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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00816576026647 | GS1 | ||||
| Primary | 00816576026654 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius