FDA UDI
In Commercial Distribution
🇺🇸 United States
Anode Buffer Container, 3500 Dx Series
DI: 10190302000185
·
Model: 4393925
·
LIFE TECHNOLOGIES, CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Anode Buffer Container, 3500 Dx Series
- Primary DI
- 10190302000185
- Version / Model
- 4393925
- Company Name
- LIFE TECHNOLOGIES, CORPORATION
- Labeler DUNS
- 078441189
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 6
- Public Version Date
- 2023-11-20
- Public Version Status
- Update
- Public Device Record Key
- 45d60105-5391-4591-91e0-6bdb90019eaf
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
- No
- 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 |
|---|---|---|---|---|
| PCA | DNA genetic analyzer | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58237 | Buffered sample diluent IVD | A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190302000185 | GS1 | ||||
| Unit of Use | 80190302000184 | GS1 |