FDA UDI
In Commercial Distribution
🇺🇸 United States
PROFI BLOT 48
DI: 09120052070507
·
Model: 09120052070507
·
Tecan Austria GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PROFI BLOT 48
- Primary DI
- 09120052070507
- Version / Model
- 09120052070507
- Catalog Number
- 30087537
- Company Name
- Tecan Austria GmbH
- Labeler DUNS
- 301237509
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-04
- Public Version
- 1
- Public Version Date
- 2020-09-14
- Public Version Status
- New
- Public Device Record Key
- e5eae5c4-4bcf-44d0-bd31-6f7ac7201386
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
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KPA | Slide Stainer, Automated | Pathology | 864.3800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62957 | Blot processor IVD | A mains electricity (AC-powered) laboratory instrument intended to be used for the processing of a prepared clinical specimen with an immobilized probe on a solid phase (e.g. blotting membrane or gel sheet) for blot assays (e.g. line assays, Western, Southern and/or Northern blot). It typically performs pre-analytical steps including (but not limited to) reagent dispensing, incubation (with or without heating), agitation and washing. The device does not include a detector and is not intended to perform qualitative and/or quantitative measurements. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09120052070507 | GS1 |
Customer Contacts
- Phone
- +18003525128
- [email protected]