HemoCue® Hb 301 Microcuvettes
HemoCue Hb 301 Microcuvettes collect and hold a small whole-blood sample for haemoglobin measurement with the Hb 301 analyser. These single-use consumables serve as both the sampling…
HemoCue Hb 301 Microcuvettes collect and hold a small whole-blood sample for haemoglobin measurement with the Hb 301 analyser. These single-use consumables serve as both the sampling pipette and the optical measuring cell.
Capillary action draws approximately 10 microlitres of blood into the microcuvette cavity without dilution or other sample preparation. The filled cuvette is placed in the analyser, which measures transmitted and scattered light and converts those measurements into a haemoglobin concentration.
Listed Item
HemoCue Hb 301 Microcuvettes 4×50 vial
Professional Testing
The Hb 301 system is intended for professional testing in primary care for people older than one month and in adult blood donation settings. The microcuvette provides the sample chamber; the separate analyser performs the measurement.
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 | Hemocue AB, Sweden |
|---|---|
| FDA product code | GKR |
| Device type | System, Hemoglobin, Automated |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5620 |
| Establishment | Manufacturer |
| 510(k) | K201217 |
| Record published | 2020-09-04 |
| Record revised | 2021-04-16 (version 5) |
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 10 to 40 °C; Storage environment temperature 50 to 104 °F; Special storage condition: An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F) |
| Packaging | Package of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 111809 | 50 | In distribution | |
| 111807 | 75 | In distribution | |
| 111814 | 75 | In distribution | |
| 111812 | 50 | In distribution | |
| 111801 | 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 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 |
| HemoCue® Hb 201 DM Analyzer | Hemocue AB | 2 |
Showing 12 of 43. All products under System, Hemoglobin, Automated
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201217 | 2020-08-04 |
| K181751 | 2019-02-01 |
| K061047 | 2006-06-08 |
| K041234 | 2004-06-10 |
| K032203 | 2003-08-25 |
| K961312 | 1996-09-24 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-07-25 | Class II | Packaging | HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches. | 42,330 packages/4 boxes/25 microcuvetes | 2014-08-11 |
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.