System Diluent
- Primary DI
- 00811403018826
- Brand
- System Diluent
- Company
- Diamond Diagnostics Inc.
- Model
- AW-SA1021D
- Published
- 2023-06-10
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00811403018826 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00811403018826 | 00811403018826 | 811403018826 | 0811403018826 |
GMDN Terms
| Term | Definition |
|---|---|
| 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). |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 947514303
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- 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 |
|---|---|---|---|---|
| 00811403010158 | Photometer Lamp | OY-MU8550D | 2023-06-13 | |
| 00811403010240 | Reference Solution | IL-09756904D | 2023-06-13 | |
| 00811403013074 | Pump Tubing Kit | CD-105673D | 2023-06-13 | |
| 00811403013173 | C1/C2 Cleaning Solution | CD-473389D | 2023-06-13 | |
| 00811403010387 | Wash Pack | CD-473497D | 2023-06-13 | |
| 00811403013296 | pH Electrode | CD-476267D | 2023-06-13 | |
| 00811403013302 | Calcium Electrode | CD-476268D | 2023-06-13 | |
| 00811403013319 | Potassium Electrode | CD-476270D | 2023-06-13 | |
| 00811403013326 | Reference Electrode | CD-476273D | 2023-06-13 | |
| 00811403013333 | Chloride Electrode | CD-476279D | 2023-06-13 | |
| 00811403013371 | Fill Solution | CD-478533D | 2023-06-13 | |
| 00811403013388 | Na-K-Ca-Cl Fill Solution | CD-478535D | 2023-06-13 | |
| 00811403013456 | Conditoner Solution | CD-478701D | 2023-06-13 | |
| 00811403013463 | Reference Solution | CD-478822D | 2023-06-13 | |
| 00811403013609 | Printer Paper | CD-67252D | 2023-06-13 | |
| 00811403013630 | Pump Tubing | CD-673705D | 2023-06-13 | |
| 00811403014040 | Salt Bridge Solution | DA-D105D | 2023-06-13 | |
| 00811403014217 | Quick IMT Sample Diluent | DA-S635D | 2023-06-13 | |
| 00811403014224 | Quick IMT Diluent Check | DA-S640D | 2023-06-13 | |
| 00811403015504 | Maintenance Kit | HM-XEA328ASD | 2023-06-13 |