QIAstat-Dx® Gastrointestinal Panel 2 691421
GUDID 04053228043249
QIAGEN GmbH
Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 04053228043249 |
| NIH Device Record Key | 3ce60e30-7f0b-4249-bd6c-9f497605c963 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QIAstat-Dx® Gastrointestinal Panel 2 |
| Version Model Number | V2 |
| Catalog Number | 691421 |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 |
Customer Support Contacts
| Phone | 800-426-8157 |
| xx@xx.xx | |
| Phone | 800-426-8157 |
| xx@xx.xx | |
| Phone | 800-426-8157 |
| xx@xx.xx | |
| Phone | 800-426-8157 |
| xx@xx.xx | |
| Phone | 800-426-8157 |
| xx@xx.xx | |
| Phone | 800-426-8157 |
| xx@xx.xx | |
| Phone | 800-426-8157 |
| xx@xx.xx | |
| Phone | 800-426-8157 |
| xx@xx.xx | |
| Phone | 800-426-8157 |
| xx@xx.xx | |
| Phone | 800-426-8157 |
| xx@xx.xx | |
| Phone | 800-426-8157 |
| xx@xx.xx | |
| Phone | 800-426-8157 |
| xx@xx.xx | |
| Phone | 800-426-8157 |
| xx@xx.xx | |
| Phone | 800-426-8157 |
| xx@xx.xx | |
| Phone | 800-426-8157 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04053228043249 [Primary] |
FDA Product Code
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay 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 | 2024-06-25 |
| Device Publish Date | 2024-06-17 |
Devices Manufactured by QIAGEN GmbH
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| 04053228048268 - QIAsymphony® DSP Circulating DNA Maxi Kit (192) | 2024-10-08 |
| 04053228048350 - QIAsymphony® DSP Circulating DNA Kit (96) | 2024-10-08 |
| 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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