QIAstat-Dx® Respiratory Panel Plus 691224
GUDID 04053228039402
IVD kit containing 6 tests
QIAGEN GmbH
Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 04053228039402 |
| NIH Device Record Key | 45a18c54-6bba-4928-845a-aaaedfdc0d8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QIAstat-Dx® Respiratory Panel Plus |
| Version Model Number | V1 |
| Catalog Number | 691224 |
| 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 | false |
| 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 | 1-800-426-8157 |
| xx@xx.xx | |
| Phone | 1-800-426-8157 |
| xx@xx.xx | |
| Phone | 1-800-426-8157 |
| xx@xx.xx | |
| Phone | 1-800-426-8157 |
| xx@xx.xx | |
| Phone | 1-800-426-8157 |
| xx@xx.xx | |
| Phone | 1-800-426-8157 |
| xx@xx.xx | |
| Phone | 1-800-426-8157 |
| xx@xx.xx | |
| Phone | 1-800-426-8157 |
| xx@xx.xx | |
| Phone | 1-800-426-8157 |
| xx@xx.xx | |
| Phone | 1-800-426-8157 |
| xx@xx.xx | |
| Phone | 1-800-426-8157 |
| xx@xx.xx | |
| Phone | 1-800-426-8157 |
| xx@xx.xx | |
| Phone | 1-800-426-8157 |
| 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 |
| 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 | 04053228039402 [Primary] |
| GS1 | 04053228047438 [Previous] |
| GS1 | 14053228039409 [Package] Package: Box contains the bas [6 Units] In Commercial Distribution |
FDA Product Code
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2026-02-05 |
| Device Publish Date | 2025-09-25 |
On-Brand Devices [QIAstat-Dx® Respiratory Panel Plus]
| 04053228047438 | V1 |
| 14053228039409 | V1 |
| 04053228039402 | IVD kit containing 6 tests |
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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