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QuantiFERON-TB Gold Blood Collection Tubes

FDA UDI

Class III (US FDA UDI)

by QIAGEN Sciences LLC

Identity

Trade Name
QuantiFERON-TB Gold Blood Collection Tubes FDA UDI
Generic Name
Interferon gamma release IVD, reagent FDA UDI
Device Name
Bulk pack FDA UDI
Model / Reference
1 FDA UDI
Description
Bulk pack FDA UDI

Identifiers

Catalog Number
T05900301 FDA UDI
Primary DI / UDI-DI
14053228002144 FDA UDI
PMA Number
P010033 FDA UDI
FDA Product Code
NCD FDA UDI
GMDN Term
Interferon gamma release IVD, reagent FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Interferon gamma release IVD, reagent

QuantiFERON-TB Gold Blood Collection Tubes 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, reagent.

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 9f46c6bd-0ad3-4d22-a558-e90a2e7e680d 35 fields · synced May 30, 2026