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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bcr/abl1 monitoring test
Definition 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.
Product CodeOYX
Regulation Number 866.6060
Device Class 2


Premarket Reviews
ManufacturerDecision
ASURAGEN, INC.
  GRANTED 1
BIO-RAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CEPHEID
  SUBSTANTIALLY EQUIVALENT 1
MOLECULARMD CORPORATION
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
SUZHOU SNIPER MEDICAL TECHNOLOGIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories II Mar-22-2024
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