Mission Plus Hemoglobin (Hb) Test Cartridges
Box of 50 Test Cartridges (5 vials of 10) and 60 Capillary Transfer Tubes (3 bags of 20)
1manufacturer
3catalogue numbers in this listing
1510(k) clearance
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 | Acon Laboratories, Inc., United States |
|---|---|
| FDA product code | GKR |
| Device type | System, Hemoglobin, Automated |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5620 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2025-06-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 59 to 86 °F; Storage environment humidity 10 to 90 % RH; Special storage condition: Store in a cool, dry place; Special storage condition: Keep out of direct sunlight |
| Packaging | Carton of 80, carton of 130 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| C132-3021 | 10 | In distribution | |
| C132-3041 | 50 | In distribution | |
| C132-3021 | 50 | 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 |
| 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 |
| HemoCue® Hb 201 DM Analyzer | Hemocue AB | 2 |
Showing 12 of 43. All products under System, Hemoglobin, Automated
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122553 | 2013-08-05 |
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.