QIAstat-Dx® Analyzer 1.0 9002824
GUDID 04053228033936
Additional Catalog Numbers: 9002814 QIAstat-Dx Analytical Module 9002813 QIAstat-Dx Operational Module DI Numbers: QIAstat-Dx Analytical Module DI Number: 04053228033929 QIAstat-Dx Operational Module DI Number: 04053228033936
QIAGEN GmbH
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated| Primary Device ID | 04053228033936 |
| NIH Device Record Key | e11a29f7-7698-4861-a3a7-dc0123d28a60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QIAstat-Dx® Analyzer 1.0 |
| Version Model Number | v1 |
| Catalog Number | 9002824 |
| Company DUNS | 317103745 |
| Company Name | QIAGEN GmbH |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04053228033936 [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 | 2019-06-03 |
| Device Publish Date | 2019-05-24 |
Devices Manufactured by QIAGEN GmbH
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| 04053228048770 - QIAcuityDx® Four | 2024-10-08 The QIAcuityDx® Four is an automated digital PCR (dPCR) instrument designed to perform amplification, detection (qualitative an |
| 04053228049418 - QIAcuityDx® Universal MasterMix Kit | 2024-10-08 The QIAcuityDx® Universal MasterMix Kit is a ready-to-use general purpose dPCR MasterMix reagent set for use with the QIAcuityD |
| 04053228049432 - QIAcuityDx® Universal MasterMix Kit | 2024-10-08 The QIAcuityDx® Universal MasterMix Kit is a ready-to-use general purpose dPCR MasterMix reagent set for use with the QIAcuityD |
| 04053228049685 - QIAcuityDx® Nanoplate 26k 24-well | 2024-10-08 The QIAcuity® Nanoplate 26k 24-well is a single use disposable that partitions samples and reaction mixes using a microfluidic |
| 04053228047582 - QIAstat-Dx Analyzer 2.0 | 2024-09-26 The QIAstat-Dx Analyzer 2.0 platform is intended as an in vitro diagnostic device for use with QIAstat-Dx assays and provides fu |
Trademark Results [QIAstat-Dx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QIASTAT-DX 88030446 not registered Live/Pending |
Qiagen GmbH 2018-07-09 |
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