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HSV Primer ASR

FDA UDI

Class I (US FDA UDI)

by Qiagen, Inc.

Identity

Trade Name
HSV Primer ASR FDA UDI
Generic Name
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, reagent FDA UDI
Model / Reference
1 FDA UDI

Identifiers

Catalog Number
1066150 FDA UDI
Primary DI / UDI-DI
04053228004363 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, reagent

HSV Primer ASR by Qiagen, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Qiagen, Inc.

Sources (1)

  • FDA UDI 44ac0000-e9d1-43c2-aaf0-ce12e11c82a1 33 fields · synced May 30, 2026