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therascreen® FGFR RGQ RT-PCR Kit

FDA UDI

Class III (US FDA UDI)

by Qiagen, Inc.

Identity

Trade Name
therascreen® FGFR RGQ RT-PCR Kit FDA UDI
Generic Name
Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3:TACC3v1 and FGFR3:TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib). Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument. FDA UDI
Model / Reference
V1 FDA UDI
Description
The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3:TACC3v1 and FGFR3:TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib). Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument. FDA UDI

Identifiers

Catalog Number
874721 FDA UDI
Primary DI / UDI-DI
04053228034094 FDA UDI
PMA Number
P180043 FDA UDI
FDA Product Code
OWD FDA UDI
GMDN Term
Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT) 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: Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)

therascreen® FGFR RGQ RT-PCR Kit by Qiagen, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT).

Cleared under the same submission

P180043 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Qiagen, Inc.

Sources (1)

  • FDA UDI 3feb004e-2717-48c3-8e3c-79278d0746b1 37 fields · synced May 30, 2026