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QuantiFERON-TB Gold Reference Lab Pack

FDA UDI

Class III (US FDA UDI)

by QIAGEN Sciences LLC

Identity

Trade Name
QuantiFERON-TB Gold Reference Lab Pack FDA UDI
Generic Name
Interferon gamma release IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
1 FDA UDI

Identifiers

Catalog Number
5940501 FDA UDI
Primary DI / UDI-DI
04053228002116 FDA UDI
PMA Number
P010033 FDA UDI
FDA Product Code
NCD FDA UDI
GMDN Term
Interferon gamma release IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class III 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Interferon gamma release IVD, kit, enzyme immunoassay (EIA)

QuantiFERON-TB Gold Reference Lab Pack by QIAGEN Sciences LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Interferon gamma release IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

P010033 also covers:

Manufacturer's product page: QuantiFERON-TB Gold Plus

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
QIAGEN Sciences LLC

Sources (1)

  • FDA UDI 7cafb5bc-d85a-4b5c-a14a-493ae2676eea 34 fields · synced May 30, 2026