HemoCue® Hb 801 Microcuvettes
HemoCue Hb 801 Microcuvettes collect and hold a whole blood sample for hemoglobin measurement in the Hb 801 analyzer. They are single use test consumables for professional point of care…
HemoCue Hb 801 Microcuvettes collect and hold a whole blood sample for hemoglobin measurement in the Hb 801 analyzer. They are single use test consumables for professional point of care testing of adults, children and infants older than one month.
Each microcuvette acts as both a sampling pipette and an optical measurement chamber. Capillary action draws approximately 10 microliters of blood into its cavity. The sample requires no dilution or other preparation before the filled cuvette is placed in the analyzer.
Listed Item
HemoCue Hb 801 Microcuvettes 4×50 vial
Compatible Samples
The system accepts capillary blood or venous whole blood collected with K2EDTA or lithium heparin. The microcuvettes contain no active reagent ingredients; the analyzer measures light transmitted and scattered through the whole blood to calculate hemoglobin concentration.
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) | K181751 |
| Record published | 2019-02-06 |
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 50 to 104 °F; Storage environment temperature 10 to 40 °C; Special storage condition: Microcuvettes in the vial (opened or unopened) can be stored for a shorter period of time (6 weeks) between -18 → 50 °C (0 |
| Packaging | Package of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 111902 | 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 |
| 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 |
|---|---|
| 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.