What is FDA product code OYX?

A BCR/ABL1 Monitoring Test is a quantitative in vitro diagnostic device used to monitor the BCR/ABL1 to ABL1 ratio by reverse-transcriptase quantitative polymerase chain reaction (RQ-PCR) on whole blood or bone marrow of diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) patients expressing BCR-ABL1 fusion transcripts such as e13a2 and/or e14a2. It is intended for use during monitoring of treatment response by reporting results on the international scale (%IS) and as log molecular reduction (MR) value.

Immunology & Microbiology › Tumor Antigen Test SystemsBcr/Abl1 Monitoring Test

QuantideX qPCR BCR-ABL IS Kit

Name: QuantideX qPCR BCR-ABL IS Kit
Brand: QuantideX qPCR BCR-ABL IS Kit

QuantideX qPCR BCR-ABL IS Kit is a molecular assay kit for measuring BCR-ABL transcript levels using quantitative PCR. It targets the major BCR-ABL breakpoints associated with chronic…

Registry build 21.09.26

QuantideX qPCR BCR-ABL IS Kit is a molecular assay kit for measuring BCR-ABL transcript levels using quantitative PCR. It targets the major BCR-ABL breakpoints associated with chronic myeloid leukemia and supports results reported on the International Scale.

The kit includes RNA-based calibrators used to quantify RNA and establish International Scale reporting. It is a molecular test reagent set, not a standalone analyzer.

Quantitative PCR Workflow

The assay uses reverse transcription and quantitative PCR to measure BCR-ABL transcripts in RNA from a sample. Calibrators support quantitative assessment and standardized reporting.

The test kit supplies assay reagents and calibrators for the molecular workflow. Its target and reporting framework are specific to the QuantideX BCR-ABL IS assay.

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code OYX
Manufacturer	City	Province	Registered as	Device types
Suzhou Sniper Medical Technologies Co., Ltd.	Suzhou	Jiangsu	Manufacturer	4

Record

Regulatory record for QuantideX qPCR BCR-ABL IS Kit
Listed by	Asuragen, Inc., United States
FDA product code	OYX
Device type	Bcr/Abl1 Monitoring Test
Device class	Class 2
Regulation	21 CFR 866.6060
Establishment	Manufacturer, Exporter
510(k)	DEN160003
Record published	2019-10-10
Record revised	2020-10-06 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number
Storage	Storage environment temperature -30 to -15 °C

Catalogue Numbers

Catalogue numbers for QuantideX qPCR BCR-ABL IS Kit
Catalogue number	Size	Status
49574		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
MRDx BCR-ABL Test	Molecularmd Corporation	1
Xpert BCR-ABL Ultra	Cepheid	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
DEN160003	2016-07-22

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.