HemoCue® Hb 801 Analyzer
The HemoCue Hb 801 Analyzer measures haemoglobin concentration in capillary or venous whole blood at the point of care. It is intended for professional in vitro diagnostic use in adults,…
The HemoCue Hb 801 Analyzer measures haemoglobin concentration in capillary or venous whole blood at the point of care. It is intended for professional in vitro diagnostic use in adults, adolescents, children and infants older than one month.
A separate single-use microcuvette fills by capillary action with approximately 10 microlitres of blood without prior dilution. The analyser measures transmitted and scattered light through that sample and uses an algorithm to calculate the haemoglobin concentration.
Listed Item
HemoCue Hb 801 Analyzer g/dL
Results and Power
The result appears on the analyser’s display. USB and Bluetooth support communication, and the unit can operate from its power adapter or rechargeable or non-rechargeable batteries. Venous samples use K2EDTA or lithium heparin.
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 |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Special storage condition: Analyzer operating and storage humidity (non-condensing) up to 90% at 25 °C (77 °F), up to 75% at 40 °C (104 °F), up to; Storage environment temperature 32 to 122 °F; Storage environment temperature 0 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 121920 | 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.