QIAstat-Dx Analyzer 2.0 9002828

GUDID 04053228047582

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Primary Device ID	04053228047582
NIH Device Record Key	b7b362c2-30e2-48a5-a906-4507c63a997e
Commercial Distribution Status	In Commercial Distribution
Brand Name	QIAstat-Dx Analyzer 2.0
Version Model Number	1
Catalog Number	9002828
Company DUNS	317103745
Company Name	QIAGEN GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	false
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	false
OTC Over-The-Counter	false

Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 55 Degrees Celsius

Device Issuing Agency	Device ID
GS1	04053228047582 [Primary]

OOI	Real Time Nucleic Acid Amplification System

Steralize Prior To Use	false
Device Is Sterile	false

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