DiaSpect Tm Cuvettes
Catalogue number 7049-3013-0369, listed by EKF Diagnostic Gmbh, Germany, under System, Hemoglobin, Automated. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
4510(k) clearances naming this product code
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
Record
| Listed by | EKF Diagnostic Gmbh, Germany |
|---|---|
| FDA product code | GKR |
| Device type | System, Hemoglobin, Automated |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5620 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | BK200520 |
| Record published | 2021-03-11 |
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 0 to 50 °C; Special storage condition: Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.) |
| Packaging | Cardboard box of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 7049-3013-0369 | 500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RAPIDPoint® 405/500 Measurement Cartridge | Siemens Healthcare Diagnostics Inc | 8 |
| McKesson | Mckesson Medical-Surgical Inc. | 6 |
| HemoCue® Hb 301 Microcuvettes | Hemocue AB | 5 |
| HemoCue® Hb 201 Microcuvettes | Hemocue AB | 4 |
| Henry Schein | Henry Schein, Inc. | 4 |
| Mission Plus Hemoglobin (Hb) Monitoring System | Acon Laboratories, Inc. | 3 |
| Mission Plus Hemoglobin (Hb) Test Cartridges | Acon Laboratories, Inc. | 3 |
| DiaSpect Tm | EKF Diagnostic Gmbh | 2 |
| HemoCue® Hb 201+ Analyzer | Hemocue AB | 2 |
| Mission Capillary Transfer Tubes | Acon Laboratories, Inc. | 2 |
| Mission Plus Hemoglobin (Hb) Optical Verifier | Acon Laboratories, Inc. | 2 |
| HemoCue® Hb301 Analyzer | Hemocue AB | 2 |
Showing 12 of 43. All products under System, Hemoglobin, Automated
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200909 | 2020-06-12 |
| K172173 | 2018-04-06 |
| K110393 | 2011-03-04 |
| K031898 | 2003-09-24 |
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.