4 results
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36ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.
FDA Recall
Completed
·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code LCP·September 18, 2024
PTS Panels CHOL+GLU Test Strips (REF 1765)
FDA Recall
Completed
·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code CGA·August 16, 2022
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.
FDA Enforcement
Class II
·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·October 30, 2024
PTS Panels CHOL+GLU Test Strips (REF 1765)
FDA Enforcement
Class III
·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·September 21, 2022