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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device antibodies, anti-cyclic citrullinated peptide (ccp)
Regulation Description Rheumatoid factor immunological test system.
Definition The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis.
Product CodeNHX
Regulation Number 866.5775
Device Class 2


Premarket Reviews
ManufacturerDecision
AXIS-SHIELD DIAGNOSTICS LIMITED.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 4 4
2017 1 1
2018 4 4
2019 13 13
2020 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 13 13
Non Reproducible Results 11 11
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 21 21
No Known Impact Or Consequence To Patient 4 4
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Euro Diagnostica AB II Aug-23-2018
2 Phadia US Inc II Feb-24-2017
3 Roche Diagnostics Operations, Inc. II Aug-23-2019
4 Siemens Healthcare Diagnostics, Inc II Sep-26-2019
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