TPLC - Total Product Life Cycle

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Device	assayed external control material for microbiology nucleic acid amplification (nat) assays
Definition	Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
Product Code	PMN
Regulation Number	866.3920
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIO-RAD LABORATORIES
	GRANTED	1
	SUBSTANTIALLY EQUIVALENT	1
BIOFIRE DEFENSE, LLC
	SUBSTANTIALLY EQUIVALENT	1
MAINE MOLECULAR QUALITY CONTROLS, INC.
	SUBSTANTIALLY EQUIVALENT	10
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MICROBIOLOGICS, INC.
	SUBSTANTIALLY EQUIVALENT	8
STRECK
	SUBSTANTIALLY EQUIVALENT	2
STRECK, INC
	SUBSTANTIALLY EQUIVALENT	1
ZEPTOMETRIX
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2023	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Human-Device Interface Problem	1	1
Fail-Safe Did Not Operate	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1	1