UltraChek Reference Controls High
Catalogue number 300-118, listed by Separation Technology, Inc., United States, under Instrument, Hematocrit, Automated. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
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 | Separation Technology, Inc., United States |
|---|---|
| FDA product code | GKF |
| Device type | Instrument, Hematocrit, Automated |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5600 |
| Record published | 2017-08-25 |
| Record revised | 2022-09-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 300-118 | 60 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 2 |
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| RAPIDPoint® 400 Measurement Cartridge | Siemens Healthcare Diagnostics Inc | 1 |
| UltraChek Reference Controls Low | Separation Technology, Inc. | 1 |
| Rapidpoint® 340/350 Valve Module | Siemens Healthcare Diagnostics Inc | 1 |
| UltraCrit (Refurbished) | Separation Technology, Inc. | 1 |
| UltraCrit Cuvettes | Separation Technology, Inc. | 1 |
| RAPIDSystems™ AutomaticQC Cartridge | Siemens Healthcare Diagnostics Inc | 1 |
| UltraCrit Loaner | Separation Technology, Inc. | 1 |
| UltraCrit QC Cuvettes | Separation Technology, Inc. | 1 |
| UltraCrit | Separation Technology, Inc. | 1 |
| UltraChek Reference Controls Normal | Separation Technology, Inc. | 1 |
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.