FDA UDI
In Commercial Distribution
🇺🇸 United States
chromID™ MRSA /SAID
DI: 03573026552091
·
Model: chromID™ MRSA /SAID
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- chromID™ MRSA /SAID
- Primary DI
- 03573026552091
- Version / Model
- chromID™ MRSA /SAID
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 5
- Public Version Date
- 2020-02-06
- Public Version Status
- Update
- Public Device Record Key
- 06e8cd8d-c755-48ed-9b57-b1fb33121444
Device Description
Chromogenic medium for the screening and qualitative detection of methicillin-resistant Staphylococcus aureus and selective isolation of staphylococci and the direct identification of S. aureus.
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
- 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 |
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 | 03573026420758 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 03573026552091 | GS1 | ||||
| Unit of Use | 03573026552107 | GS1 |
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius