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Xpert BCR-ABL Ultra

FDA UDI

Class II (US FDA UDI)

by Cepheid

Identity

Trade Name
Xpert BCR-ABL Ultra FDA UDI
Generic Name
Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
Xpert BCR-ABL Ultra test; 10 test kit FDA UDI
Model / Reference
GXBCRABL-US-10 FDA UDI
Description
Xpert BCR-ABL Ultra test; 10 test kit FDA UDI

Identifiers

Catalog Number
GXBCRABL-US-10 FDA UDI
Primary DI / UDI-DI
07332940007102 FDA UDI
510(k) Number
K190076 FDA UDI
FDA Product Code
OYX FDA UDI
GMDN Term
Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.6060 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

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: Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT)

Xpert BCR-ABL Ultra by Cepheid — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cepheid

Sources (1)

  • FDA UDI 5b24dea1-190d-4e6c-87a4-6dd2c5474875 37 fields · synced Jun 1, 2026