FDA UDI
In Commercial Distribution
🇺🇸 United States
CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood (CPSE/CNA)
DI: 03573026600426
·
Model: CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood (CPSE/CNA)
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood (CPSE/CNA)
- Primary DI
- 03573026600426
- Version / Model
- CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood (CPSE/CNA)
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-05-19
- Public Version
- 1
- Public Version Date
- 2020-05-27
- Public Version Status
- New
- Public Device Record Key
- f2aec207-bdab-4aa2-9de4-48d76e00dcaf
Device Description
This product consists of two culture media, dispensed into one Petri dish containing separate compartments. It is intended for use with urine specimens
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
- 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 |
|---|---|---|---|---|
| JXA | KIT, SCREENING, URINE | Microbiology | 866.2660 | 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 |
|---|---|---|---|---|---|---|
| Package | 03573026468545 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 03573026600426 | GS1 | ||||
| Unit of Use | 03573026600433 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius