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MRDx BCR-ABL Test

FDA UDI

Class II (US FDA UDI)

by Molecularmd Corporation

Identity

Trade Name
MRDx BCR-ABL Test FDA UDI
Generic Name
Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
The MRDx Test utilizes quantitative, real-time reverse transcription polymerase chain reaction (RT-qPCR) for BCR-ABL and ABL quantitation. The rapid, one-step protocol allows for both reverse transcription and quantitative PCR reactions to be performed in the same well. This provide the advantage of increase sensitivity while limiting experimental variables and also reducing time and cost. The MRDx BCR-ABL Test uses BCR-ABL and ABL standard curves to determine BCR-ABL and ABL copy numbers. The assay has been harmonized to the WHO primary standards for determination of Major Molecular Response (MMR) levels based on the International Scale (IS). Major Molecular Response (MMR) or MR3, defined as greater than or equal to a 3-log reduction in the ration of BCR-ABL/ABL from a standardized baseline value, reflects a patient's response to treatment. In addition, the MRDx BCR-ABL Test includes MR4.5 to enable quantification to 0.0032% IS, which is greater than a 4-log reduction, important for treatment discontinuation and for monitoring of treatment-free remission. FDA UDI
Model / Reference
901-0028 FDA UDI
Description
The MRDx Test utilizes quantitative, real-time reverse transcription polymerase chain reaction (RT-qPCR) for BCR-ABL and ABL quantitation. The rapid, one-step protocol allows for both reverse transcription and quantitative PCR reactions to be performed in the same well. This provide the advantage of increase sensitivity while limiting experimental variables and also reducing time and cost. The MRDx BCR-ABL Test uses BCR-ABL and ABL standard curves to determine BCR-ABL and ABL copy numbers. The assay has been harmonized to the WHO primary standards for determination of Major Molecular Response (MMR) levels based on the International Scale (IS). Major Molecular Response (MMR) or MR3, defined as greater than or equal to a 3-log reduction in the ration of BCR-ABL/ABL from a standardized baseline value, reflects a patient's response to treatment. In addition, the MRDx BCR-ABL Test includes MR4.5 to enable quantification to 0.0032% IS, which is greater than a 4-log reduction, important for treatment discontinuation and for monitoring of treatment-free remission. FDA UDI

Identifiers

Catalog Number
901-0028 FDA UDI
Primary DI / UDI-DI
B60290100280 FDA UDI
510(k) Number
K173492 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)

MRDx BCR-ABL Test by Molecularmd Corporation — 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
Molecularmd Corporation

Sources (1)

  • FDA UDI 99642795-6c90-4012-adca-5328544658ba 36 fields · synced Jun 1, 2026