54 results
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27ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·October 27, 2021
FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. " It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company, BD Bio Sciences·January 1, 2025
GEM Premier 5000 PAK, Part No. 00055360004.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000; Part No. 00055445004.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000 PAK; Part No. 00055360010.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000; Part No. 00055415005.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000; Part No. 00055445008.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000 PAK; Part No. 00055407504.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000; Part No. 00055430011.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000; Model No. 00055430010.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000; Part No. 00055415008.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000 PAK; Part No. 00055360008.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000; Part No. 00055445010 & 00055445011.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000 PAK; Part No. 00055407511.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000; Part No. 00055415010.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000 PAK; Part No. 00055407508.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000 PAK; Part No. 00055407510.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000; Part No: 00055415011.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000; Part No. 00055430008.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026
GEM Premier 5000 PAK; Part No. 00055360011.
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·March 18, 2026