FDA UDI
In Commercial Distribution
🇺🇸 United States
STA® - Stachrom® Plasminogen
DI: 03607450006582
·
Model: 00658
·
DIAGNOSTICA STAGO
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STA® - Stachrom® Plasminogen
- Primary DI
- 03607450006582
- Version / Model
- 00658
- Company Name
- DIAGNOSTICA STAGO
- Labeler DUNS
- 262277122
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 4
- Public Version Date
- 2021-05-03
- Public Version Status
- Update
- Public Device Record Key
- 41324679-3415-45a3-b70e-b38eb65ee925
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| DDX | PLASMINOGEN, ANTIGEN, ANTISERUM, CONTROL | Immunology | 866.5715 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56125 | Plasminogen IVD, kit, chromogenic | A collection of reagents and other associated materials intended to be used for the quantitative measurement of plasminogen in a clinical specimen, using a chromogenic method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03607450006582 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K832591 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius