FDA UDI
In Commercial Distribution
🇺🇸 United States
STA® - Cephascreen® 10
DI: 13607450003106
·
Model: 00310
·
DIAGNOSTICA STAGO
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- STA® - Cephascreen® 10
- Primary DI
- 13607450003106
- Version / Model
- 00310
- Company Name
- DIAGNOSTICA STAGO
- Labeler DUNS
- 262277122
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 5
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 7536ef24-da28-443b-908a-b3cf2811da01
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 |
|---|---|---|---|---|
| GFO | ACTIVATED PARTIAL THROMBOPLASTIN | Hematology | 864.7925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55981 | Activated partial thromboplastin time (APTT) IVD, kit, clotting | A collection of reagents and other associated materials intended to be used for the quantitative measurement of the activated partial thromboplastin time (APTT) of a clinical specimen using a clotting method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 13607450003106 | GS1 | ||||
| Unit of Use | 03607450003109 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius