FDA UDI
In Commercial Distribution
🇺🇸 United States
Total Protein Kit (Biuret Method) (2-Part Reagents)
DI: 06970291985208
·
Model: None
·
Medicalsystem Biotechnology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Total Protein Kit (Biuret Method) (2-Part Reagents)
- Primary DI
- 06970291985208
- Version / Model
- None
- Company Name
- Medicalsystem Biotechnology Co., Ltd.
- Labeler DUNS
- 545261989
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-07
- Public Version
- 1
- Public Version Date
- 2019-03-15
- Public Version Status
- New
- Public Device Record Key
- 22629c34-6e7c-499e-bd4c-7d4e12fb1f9f
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | Clinical Chemistry | 862.1635 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53985 | Total protein IVD, kit, enzyme spectrophotometry | A collection of reagents and other associated materials intended to be used for the quantitative measurement of total protein in a clinical specimen, using an enzyme spectrophotometry method. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970291985208 | GS1 |