QIAstat-Dx® Respiratory Panel Plus 691224

GUDID 14053228039409

QIAGEN GmbH

Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID14053228039409
NIH Device Record Key45a18c54-6bba-4928-845a-aaaedfdc0d8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameQIAstat-Dx® Respiratory Panel Plus
Version Model NumberV1
Catalog Number691224
Company DUNS317103745
Company NameQIAGEN GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-426-8157
Emailxx@xx.xx
Phone1-800-426-8157
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS114053228039409 [Primary]

FDA Product Code

QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-03
Device Publish Date2025-09-25

On-Brand Devices [QIAstat-Dx® Respiratory Panel Plus]

04053228047438V1
14053228039409V1

Trademark Results [QIAstat-Dx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QIASTAT-DX
QIASTAT-DX
88030446 not registered Live/Pending
Qiagen GmbH
2018-07-09

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.