Primary Device ID | 14053228039409 |
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 | 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 |
Phone | 1-800-426-8157 |
xx@xx.xx | |
Phone | 1-800-426-8157 |
xx@xx.xx |
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 Issuing Agency | Device ID |
---|---|
GS1 | 14053228039409 [Primary] |
QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-10-03 |
Device Publish Date | 2025-09-25 |
04053228047438 | V1 |
14053228039409 | V1 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() QIASTAT-DX 88030446 not registered Live/Pending |
Qiagen GmbH 2018-07-09 |