FDA UDI
In Commercial Distribution
🇺🇸 United States
FBB-ALKALINE SOLUTION
DI: 04061838203502
·
Model: 863-10ML
·
Sigma-Aldrich, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FBB-ALKALINE SOLUTION
- Primary DI
- 04061838203502
- Version / Model
- 863-10ML
- Company Name
- Sigma-Aldrich, Inc.
- Labeler DUNS
- 832563121
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-21
- Public Version
- 2
- Public Version Date
- 2022-05-11
- Public Version Status
- Update
- Public Device Record Key
- ca70a214-a59a-4c90-b7e4-f29924ef28f4
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
- 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 |
|---|---|---|---|---|
| JCJ | Alkaline Phosphatase | Hematology | 864.7660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52931 | Alkaline phosphatase (ALP) isoenzyme 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 quantitative measurement of one or multiple alkaline phosphatase (ALP) isoenzymes in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04061838203502 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius