ContrIL Spectrum Control, Level 1
Catalogue number 00009833750, listed by Instrumentation Laboratory SPA, Italy, under Controls For Blood-Gases, (Assayed And Unassayed). 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Instrumentation Laboratory SPA, Italy |
|---|---|
| FDA product code | JJS |
| Device type | Controls For Blood-Gases, (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2021-07-13 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Store ContrIL Spectrum at 2-8°C (the product is stable for only 120 days if stored at 15- 25°C). Protect from direct sun |
| Distribution end date | 2018-03-09 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 00009833750 | 50 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Liquichek | Bio-Rad Laboratories Inc. | 16 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 11 |
| Architect | Abbott Laboratories | 7 |
| Stat Profile | Nova Biomedical Corporation | 7 |
| Blood Gas and Electrolyte Control | Edan Instruments, Inc. | 3 |
| VKR-7 | Radiometer America, Inc. | 1 |
| Mission Control, Level 1 | Diamond Diagnostics Inc. | 1 |
| Autocheck 3+, Level 1, S7335 | Radiometer Medical APS | 1 |
| Autocheck 3+, Level 4, S7365 | Radiometer Medical APS | 1 |
| Qualicheck 5+, Level 4 | Radiometer Medical APS | 1 |
| Qualicheck 5+, Level 3 | Radiometer Medical APS | 1 |
| QC Adaptor | Radiometer Medical APS | 1 |
Showing 12 of 45. All products under Controls For Blood-Gases, (Assayed And Unassayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K972861 | 1997-08-19 |
| K811143 | 1981-05-13 |
| K770228 | 1977-06-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.