Stat Profile
Prime Sensor Card CCS (High Volume)
1manufacturer
2catalogue numbers in this listing
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 | Nova Biomedical Corporation, United States |
|---|---|
| FDA product code | GKF |
| Device type | Instrument, Hematocrit, Automated |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5600 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K141907 |
| Record published | 2017-07-06 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 20 to 85 % RH; Handling environment temperature 15 to 32 °C; Storage environment temperature 15 to 32 °C; Special storage condition: Without Condensation; Special storage condition: 0 ft to 12000 ft |
| Packaging | Box, carton |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRIME CCS | In distribution | |
| PRIME CCS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RAPIDPOINT®340/350 pH Electrode | Siemens Healthcare Diagnostics Inc | 1 |
| 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 |
| UltraChek Reference Controls High | Separation Technology, 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K981426 | 1998-05-12 |
| K981427 | 1998-05-12 |
| K981425 | 1998-05-12 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Nova Biomedical Corporation | 510(k) number | 2017-06-19 | Class II | Software design | Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results. | 179 units (US) and 904 (OUS) Total 1083 | 2018-08-14 |
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.