QIAstat-Dx® Respiratory Panel

FDA UDI

Class II (US FDA UDI)

by Qiagen, Inc.

Identity

Trade Name: QIAstat-Dx® Respiratory Panel FDA UDI
Generic Name: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Model / Reference: V1 FDA UDI

Identifiers

Catalog Number: 691221 FDA UDI
Primary DI / UDI-DI: 04053228033905 FDA UDI
FDA Product Code: OZZ FDA UDI
OQW FDA UDI
OZY FDA UDI
OZX FDA UDI
OTG FDA UDI
OOI FDA UDI
OEP FDA UDI
OOU FDA UDI
OEM FDA UDI
OCC FDA UDI
GMDN Term: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3980 FDA UDI
866.3332 FDA UDI
862.2570 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

QIAstat-Dx® Respiratory Panel by Qiagen, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Qiagen, Inc.

Sources (1)

FDA UDI b06cbff6-fc22-4b51-a491-78d026ff588b 35 fields · synced May 30, 2026