QuarkBio® QST-Dx1000-1
GUDID 04719890680013
Q Station™ Dx 1000
QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)
Thermal cycler nucleic acid amplification analyser IVD, laboratory| Primary Device ID | 04719890680013 |
| NIH Device Record Key | 0b8c2f9c-dcbb-425c-bf0f-b71c3b8c99ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QuarkBio® |
| Version Model Number | Q Station |
| Catalog Number | QST-Dx1000-1 |
| Company DUNS | 658577756 |
| Company Name | QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT) |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com | |
| Phone | +88636590898 |
| support@quarkbiotechnology.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719890680013 [Primary] |
FDA Product Code
| OOI | Real Time Nucleic Acid Amplification System |
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 | 2023-12-20 |
| Device Publish Date | 2023-12-12 |
On-Brand Devices [QuarkBio®]
| 04719890680020 | Q Station™ Dx 1000 |
| 04719890680013 | Q Station™ Dx 1000 |
Trademark Results [QuarkBio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUARKBIO 87355456 not registered Live/Pending |
QUARK BIOSCIENCES, INC. 2017-03-02 |
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