FDA UDI
In Commercial Distribution
🇺🇸 United States
TRIZMA® CONCENTRATE
DI: 04061838789686
·
Model: 3913-50ML
·
Sigma-Aldrich, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TRIZMA® CONCENTRATE
- Primary DI
- 04061838789686
- Version / Model
- 3913-50ML
- Company Name
- Sigma-Aldrich, Inc.
- Labeler DUNS
- 832563121
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-24
- Public Version
- 1
- Public Version Date
- 2022-11-01
- Public Version Status
- New
- Public Device Record Key
- b66406eb-0920-4524-8d2c-b181feb09bf6
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GIA | Test, Leukocyte Peroxidase | Hematology | 864.7675 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53131 | Myeloperoxidase (MPO) 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 qualitative and/or quantitative detection of the enzyme myeloperoxidase (MPO) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04061838789686 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 26 Degrees Celsius