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Xpert BCR-ABL IS p210 Linearity Panel C207

FDA UDI

Class II (US FDA UDI)

by Mmqci

Identity

Trade Name
Xpert BCR-ABL IS p210 Linearity Panel C207 FDA UDI
Generic Name
Philadelphia chromosome/BCR-ABL transcript IVD, control FDA UDI
Device Name
Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system. FDA UDI
Model / Reference
v.00 FDA UDI
Description
Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system. FDA UDI

Identifiers

Catalog Number
C207 FDA UDI
Primary DI / UDI-DI
00852720008183 FDA UDI
FDA Product Code
QIG FDA UDI
GMDN Term
Philadelphia chromosome/BCR-ABL transcript IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

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: Philadelphia chromosome/BCR-ABL transcript IVD, control

Xpert BCR-ABL IS p210 Linearity Panel C207 by Mmqci — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Philadelphia chromosome/BCR-ABL transcript IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mmqci

Sources (1)

  • FDA UDI 4c7afa54-6bac-4363-a805-9a164e9c4441 36 fields · synced May 30, 2026