FDA UDI
In Commercial Distribution
🇺🇸 United States
Trypsin-RIA
DI: 05400569001411
·
Model: KIPCE07
·
Diasource Immunoassays S.A. SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trypsin-RIA
- Primary DI
- 05400569001411
- Version / Model
- KIPCE07
- Company Name
- Diasource Immunoassays S.A. SA
- Labeler DUNS
- 458777323
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-29
- Public Version
- 1
- Public Version Date
- 2020-02-06
- Public Version Status
- New
- Public Device Record Key
- 9de65bda-bd30-49c1-bfed-09ecc1129efa
Device Description
Trypsin-RIA
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JNO | N-BENZOYL-L-ARGININE ETHYL ESTER (U.V.), TRYPSIN | Clinical Chemistry | 862.1725 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53178 | Trypsin IVD, kit, radioimmunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement of trypsin in a clinical specimen, using a radioimmunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05400569001411 | GS1 |