HemoCue® WBC Microcuvettes 113003
GUDID 07311091130037
HemoCue WBC Microcuvettes 4x40 vial
Hemocue AB
Haematological cell analyser IVD, semi-automated| Primary Device ID | 07311091130037 |
| NIH Device Record Key | 5e4f08b4-668e-4669-9c61-c5be02afa6ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HemoCue® WBC Microcuvettes |
| Version Model Number | 113003 |
| Catalog Number | 113003 |
| Company DUNS | 356164426 |
| Company Name | Hemocue AB |
| Device Count | 40 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07311091130037 [Package] Contains: 17311091130034 Package: package [4 Units] In Commercial Distribution |
| GS1 | 17311091130034 [Primary] |
| GS1 | 27311091130031 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071652
FDA Product Code
| GKL | Counter, Cell, Automated (Particle Counter) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-05-31 |
Devices Manufactured by Hemocue AB
| 27311091118077 - HemoCue® Hb 301 Microcuvettes | 2022-11-07 HemoCue Hb 301 Microcuvettes 4x75 vial |
| 27311091118121 - HemoCue® Hb 301 Microcuvettes | 2022-09-07 HemoCue Hb 301 Microcuvettes 4x50 vial |
| 07311091218278 - HemoCue® Hb301 Analyzer | 2020-09-14 HemoCue Hb301 Analyzer g/dL |
| 07311091118097 - HemoCue® Hb 301 Microcuvettes | 2020-09-14 HemoCue Hb 301 Microcuvettes 4x50 vial |
| 07311091391681 - HemoCue® 801 Connect | 2019-07-02 HemoCue® 801 Connect |
| 07311091206237 - HemoCue® Albumin 201 Analyzer | 2019-05-03 HemoCue Albumin 201 Analyzer mg/L |
| 17311091106084 - HemoCue® Urine Albumin Microcuvettes | 2019-05-03 HemoCue Urine Albumin Microcuvettes 2x25 single |
| 17311091119022 - HemoCue® Hb 801 Microcuvettes | 2019-03-11 HemoCue Hb 801 Microcuvettes 4x50 vial |
Trademark Results [HemoCue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOCUE 77756134 3912761 Live/Registered |
HemoCue AB 2009-06-10 |
 HEMOCUE 73352049 1222479 Dead/Cancelled |
Aktiebolaget Leo 1982-02-26 |
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