SYSTEM SOLUTION For Viva Drug Testing System
- Primary DI
- 03661540217500
- Brand
- SYSTEM SOLUTION For Viva Drug Testing System
- Company
- ELITECH CLINICAL SYSTEMS SAS
- Model
- 3203-063
- Published
- 2020-09-25
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 03661540217500 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 03661540217500 | 03661540217500 | 3661540217500 |
GMDN Terms
| Term | Definition |
|---|---|
| Buffered wash solution IVD, automated/semi-automated system | A buffered wash solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 267732378
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 03661540200809 | ENVOY 500 ALT REAGENT KIT | 55215 | 2016-09-24 | |
| 03661540201905 | ENVOY 500 CREATININE REAGENT KIT | 55335 | 2016-09-24 | |
| 03661540202506 | ENVOY 500 ISE BASELINE SOLUTION KIT | 55381 | 2016-09-24 | |
| 03661540202605 | ENVOY 500 ISE CALIBRATOR KIT | 55117 | 2016-09-24 | |
| 03661540202803 | ENVOY 500 ISE REFERENCE SOLUTION KIT | 55382 | 2016-09-24 | |
| 03661540202902 | ENVOY 500 LDL CALIBRATOR KIT | 55115 | 2016-09-24 | |
| 03661540203602 | ENVOY 500 TOTAL PROTEIN REAGENT KIT | 55425 | 2016-09-24 | |
| 03661540203800 | ENVOY 500 BUN REAGENT KIT | 55445 | 2016-09-24 | |
| 03661540213106 | ALT/GPT 4+1 SL | ALSL-0250 | 2016-09-24 | |
| 03661540214301 | CREATININE PAP SL | CRSL-0250 | 2016-09-24 | |
| 03661540214806 | HbA1c CALIBRATOR SET | HBAC-0043 | 2016-09-24 | |
| 03661540214905 | HbA1c CONTROL L+ H | HBAC-0049 | 2016-09-24 | |
| 03661540215001 | HbA1c | HBAC-0240 | 2016-09-24 | |
| 03661540215308 | ISE CALIBRATORS | ISCA-0250 | 2016-09-24 | |
| 03661540215407 | ISE CLEANER/CONDITIONER | ISCC-0280 | 2016-09-24 | |
| 03661540215605 | ISE REFERENCE SOLUTION | ISRS-0800 | 2016-09-24 | |
| 03661540215704 | CHOLESTEROL LDL 2G CALIBRATOR | LDLL-0041 | 2016-09-24 | |
| 03661540216404 | TOTAL PROTEIN PLUS | PROB-0250 | 2016-09-24 | |
| 03661540216800 | UREA UV SL | URSL-0250 | 2016-09-24 | |
| 03661540200908 | ENVOY 500 AMYLASE REAGENT KIT | 55245 | 2016-09-24 |