FDA UDI
In Commercial Distribution
🇺🇸 United States
ScheBo® Extraction buffer
DI: 04260152080206
·
Model: 5x
·
ScheBo r. Biotech Aktiengesellschaft
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ScheBo® Extraction buffer
- Primary DI
- 04260152080206
- Version / Model
- 5x
- Catalog Number
- 02
- Company Name
- ScheBo r. Biotech Aktiengesellschaft
- Labeler DUNS
- 326980364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-30
- Public Version
- 2
- Public Version Date
- 2020-11-06
- Public Version Status
- Update
- Public Device Record Key
- ea4a11ff-4bec-43d9-9d41-f09a8fea21a5
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| JCC | Ph Buffer | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62669 | Clinical specimen extraction buffer IVD | A buffered solution intended to be used for the processing and preparation of a clinical specimen, for subsequent in vitro diagnostic testing, by extraction of specific target analytes present in the clinical specimen (e.g., proteins, antigens). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260152080206 | GS1 |