Quantum Blue® Reader
GUDID EBUHBIPOCTRABS0
Bühlmann Laboratories AG
Photometric immunoassay analyser IVD Photometric immunoassay analyser IVD Photometric immunoassay analyser IVD Photometric immunoassay analyser IVD Photometric immunoassay analyser IVD Photometric immunoassay analyser IVD Photometric immunoassay analyser IVD Photometric immunoassay analyser IVD Photometric immunoassay analyser IVD Photometric immunoassay analyser IVD Photometric immunoassay analyser IVD Photometric immunoassay analyser IVD Photometric immunoassay analyser IVD Photometric immunoassay analyser IVD Photometric immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic 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 |
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