FDA UDI
In Commercial Distribution
🇺🇸 United States
API®50 CHB/E
DI: 03573026588724
·
Model: API®50 CHB/E
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- API®50 CHB/E
- Primary DI
- 03573026588724
- Version / Model
- API®50 CHB/E
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-10
- Public Version
- 1
- Public Version Date
- 2020-04-20
- Public Version Status
- New
- Public Device Record Key
- 7f3443cb-0353-4fc1-a4d0-a6065cc19c73
Device Description
API 50 CHB/E Medium is for ID of Bacillus, related genera, and GN rods (Enterobacteriaceae and Vibrionaceae). It allows fermentation of 49 carbohydrates on API 50 CH strip
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 |
|---|---|---|---|---|
| JSC | CULTURE MEDIA, GENERAL NUTRIENT BROTH | Microbiology | 866.2350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50416 | Multiple Enterobacteriaceae species culture isolate identification IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the differentiation and/or identification of one or multiple species of oxidase negative, gram negative bacteria belonging to the Enterobacteriaceae family, that have been isolated by culture from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03573026087494 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 03573026588724 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius