Quantum Blue® Reader
GUDID EBUHBIPOCTRABS0
Bühlmann Laboratories AG
Photometric immunoassay analyser IVD| Primary Device ID | EBUHBIPOCTRABS0 |
| NIH Device Record Key | e28ce1d1-bcfa-4da6-8117-0b04d86b944b |
| Commercial Distribution Discontinuation | 2021-01-12 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Quantum Blue® Reader |
| Version Model Number | BI-POCTR-ABS |
| Company DUNS | 481261006 |
| Company Name | Bühlmann Laboratories AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com |
Operating and Storage Conditions
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBUHBIPOCTRABS0 [Primary] |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-20 |
| Device Publish Date | 2021-01-12 |
Devices Manufactured by Bühlmann Laboratories AG
| EBUHBCALSAMPLER250 - Simple Sampler Stool Collection Set | 2023-07-04 |
| EBUHBKCALRSETUS0 - BÜHLMANN fCAL® turbo Reagent Kit | 2023-05-10 |
| 04260714340007 - fCAL turbo | 2022-06-21 |
| 07613336169926 - fCAL turbo | 2022-06-10 |
| EBUH089104991900 - fCAL Calibrator Set | 2022-06-10 |
| EBUH089109870010 - CALEX Cap | 2021-07-22 |
| EBUHBIPOCTRABS0 - Quantum Blue® Reader | 2021-01-20 |
| EBUHBIPOCTRABS0 - Quantum Blue® Reader | 2021-01-20 |
| EBUHBKPELACONSET0 - BÜHLMANN fPELA® turbo Control Kit | 2020-06-30 |
Trademark Results [Quantum Blue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUANTUM BLUE 97539739 not registered Live/Pending |
Samsung Display Co., Ltd. 2022-08-08 |
 QUANTUM BLUE 79065482 3832009 Live/Registered |
Bühlmann Laboratories AG 2009-02-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.