Home GUDID 08426950497059 ACL AcuStar cuvettes (1400 pcs)
Primary DI 08426950497059
Brand ACL AcuStar cuvettes (1400 pcs)
Company INSTRUMENTATION LABORATORY COMPANY
Model 0009801100
Catalog number 0009801100
Device description ACL AcuStar cuvettes (1400 pcs)
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name GKP INSTRUMENT, COAGULATION, AUTOMATED
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GKP Instrument, Coagulation, Automated Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08426950497059 Primary GS1 0 18426950497056 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08426950497059 08426950497059 8426950497059 18426950497056 18426950497056
GMDN Terms# Term, Definition table Term Definition Coagulation analyser IVD, laboratory, automated A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection. The device operates with minimal technician involvement and complete automation of all procedural steps.
Regulatory Flags# DUNS number 557223252 Device count 1400 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08430793242998 HEMOSIL RIVAROXABAN CONTROLS 0020015500 00020015500 2024-07-22 08430793243001 HEMOSIL RIVAROXABAN CALIBRATORS 0020015400 00020015400 2024-07-22 00195226001129 HemosIL Chromogenic Factor IX 0020012900 0020012900 2024-07-09 00195226000528 ACL TOP 770 00000280057 00000280057 2024-05-15 00195226000535 ACL TOP 770 LAS 00000280037 00000280037 2024-05-15 00195226000542 ACL TOP 770s 00000280017 00000280017 2024-05-15 00195226000559 ACL TOP 570 00000280047 00000280047 2024-05-15 00195226000566 ACL TOP 370 00000280067 00000280067 2024-05-15 00195226000641 GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests) 00077430010 2023-10-03 00195226000627 GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 600 Tests) 00077445010 2023-10-02 00195226000634 GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 450 Tests) 00077445010 2023-10-02 00195226000658 GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 150 Tests) 00077415010 2023-10-02 00195226000665 GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 75 Tests) 00077407510 2023-10-02 00195226000672 GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 600 Tests) 00077360011 2023-10-02 00195226000689 GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests) 00077445011 2023-10-02 00195226000696 GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 300 Tests) 00077445010 2023-10-02 00195226000702 GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 150 Tests) 00077445010 2023-10-02 00195226000719 GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 75 Tests) 00077445010 2023-10-02 00195226000726 GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 600 Tests) 00077360008 2023-10-02 00195226000733 GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 450 Tests) 00077445008 2023-10-02
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