FDA UDI
In Commercial Distribution
🇺🇸 United States
Trypcase Soy Broth
DI: 03573026073589
·
Model: 42100
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Trypcase Soy Broth
- Primary DI
- 03573026073589
- Version / Model
- 42100
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2019-07-19
- Public Version
- 2
- Public Version Date
- 2019-11-21
- Public Version Status
- Update
- Public Device Record Key
- b139b28c-e1e1-4343-9100-4c6093cb7e90
Device Description
Trypcase Soy broth is a culture medium for the growth of most non-fastidious micro-organisms (bacteria and fungi)
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 |
|---|---|---|---|---|
| JSG | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | Microbiology | 866.2300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58586 | Basic/simple nutrient broth culture medium IVD | A non-selective, non-differential nutrient broth culture medium intended to be used to for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03573026073589 | GS1 | ||||
| Unit of Use | 03573026598426 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius