FDA 510(k) Premarket Notification K142878: IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material

Trividia Health, Inc. Registration: 1000113657 View Registration

Sixarp LLC, Praxis Registration: 1000115322 View Registration

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LGC Clinical Diagnostics, Inc. Registration: 1226774 View Registration

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A-S MEDICATION SOLUTIONS LLC Registration: 1450743 View Registration

STANBIO LABORATORY Registration: 1616487 View Registration

HELENA LABORATORIES, CORP. Registration: 1618982 View Registration

Fujirebio Diagnostics, Inc. Registration: 1643621 View Registration

SA SCIENTIFIC, LTD Registration: 1645225 View Registration

GERMAINE LABORATORIES, INC. Registration: 1649661 View Registration

ELITechGroup Inc Registration: 1717966 View Registration

ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration

CLINICAL INNOVATIONS, LLC Registration: 1722684 View Registration

Ascensia Diabetes Care US Inc. Registration: 1810909 View Registration

Analytical Control Systems Registration: 1825740 View Registration

HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration

TECO DIAGNOSTICS Registration: 1832216 View Registration

ARKRAY FACTORY USA, INC. Registration: 1832816 View Registration

Bio-Rad Laboratories Inc. Registration: 2016706 View Registration

QUANTIMETRIX CORP. Registration: 2020715 View Registration

DiaSorin Molecular LLC Registration: 2023365 View Registration

QUIDEL CORP. Registration: 2024674 View Registration

Hologic, Inc. Registration: 2024800 View Registration

INOVA DIAGNOSTICS, INC. Registration: 2026994 View Registration

Sekisui Diagnostics, LLC Registration: 2030538 View Registration

JANT PHARMACAL CORP. Registration: 2030633 View Registration

Carolina Liquid Chemistries Corp. Registration: 2030861 View Registration

QUALIGEN, INC. Registration: 2032087 View Registration

Isomedix Operations, Inc Registration: 2032098 View Registration

CTK BIOTECH, INC. Registration: 2032682 View Registration

Diazyme Laboratories, Inc. Registration: 2032900 View Registration

BECKMAN COULTER, INC. Registration: 2050010 View Registration

BECKMAN COULTER, INC. Registration: 2050012 View Registration

KAMIYA BIOMEDICAL COMPANY LLC Registration: 2084025 View Registration

CLINIQA CORPORATION Registration: 2085064 View Registration

BECKMAN COULTER, INC. Registration: 2122870 View Registration

WATERS MEDICAL SYSTEMS, LLC Registration: 2123774 View Registration

Spartronics Watertown LLC Registration: 2133772 View Registration

FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office Registration: 2155 View Registration

DIASORIN INC. Registration: 2182595 View Registration

DRG International, Inc. Registration: 2245285 View Registration

DIAGNOSTICA STAGO, INC. Registration: 2245451 View Registration

ABBOTT POINT OF CARE INC. Registration: 2245578 View Registration

PRINCETON BIOMEDITECH CORP. Registration: 2246703 View Registration

ALFA WASSERMANN Registration: 2247288 View Registration

ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration

Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration

BIOCHEMICAL DIAGNOSTICS, INC. Registration: 2432495 View Registration

CATACHEM, INC. Registration: 2434178 View Registration

POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC. Registration: 2435505 View Registration

Fujirebio Diagnostics, Inc. Registration: 2521625 View Registration

ACON LABORATORIES, INC. Registration: 2531491 View Registration

Bio-Rad Laboratories, Inc. Registration: 2915274 View Registration

ABBOTT DIABETES CARE INC. Registration: 2954323 View Registration

HORIBA ABX SAS Registration: 3000148879 View Registration

Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration

LIFESCAN SCOTLAND LTD Registration: 3001058982 View Registration

SERVICE GRAPHICS, INC. Registration: 3001452053 View Registration

Siemens Healthcare Diagnostics Inc Registration: 3002637618 View Registration

Ortho Clinical Diagnostics Registration: 3002642396 View Registration

Canon Medical Diagnostics Corporation Fuji Plant. Registration: 3002694097 View Registration

LABORATORIOS SCANTIBODIES S.A. DE C.V. Registration: 3002792284 View Registration

DRG INSTRUMENTS GMBH Registration: 3002800697 View Registration

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration

TAKASAKI PLANT, NIPPON KAYAKU CO., LTD. Registration: 3002807722 View Registration

ABBOTT GmbH Registration: 3002809144 View Registration

Fujirebio Inc. Registration: 3002895169 View Registration

TYSON BIORESEARCH, INC. Registration: 3003132490 View Registration

FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) Registration: 3003419906 View Registration

ARKRAY Factory, Inc. Registration: 3003422726 View Registration

Agilent Technologies Singapore (International) Pte Ltd. Registration: 3003423869 View Registration

Nagase Diagnostics Co., Ltd. Registration: 3003460426 View Registration

FUJIFILM Healthcare Manufacturing Corporation MIE Office Registration: 3003522182 View Registration

SEKISUI MEDICAL CO., LTD. Tsukuba Plant Registration: 3003539867 View Registration

Tecan Trading AG Registration: 3003559191 View Registration

B.R.A.H.M.S GmbH Registration: 3003561301 View Registration

Infrared Laboratory Systems dba SYNERMED Registration: 3003593973 View Registration

Flextronics Manufacturing Aguascalientes, S.A de C.V Registration: 3003600763 View Registration

LGC Clinical Diagnostics, Inc. Registration: 3003610890 View Registration

MedSource Labs, LLC Registration: 3003674698 View Registration

DIRUI INDUSTRIAL CO., LTD. Registration: 3003741796 View Registration

DIAGAM S.A. Registration: 3003749380 View Registration

DENKA CO., LTD. Registration: 3003871639 View Registration

HMD BIOMEDICAL, INC. Registration: 3003902721 View Registration

BTNX Inc. Registration: 3003917514 View Registration

CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH Registration: 3003951180 View Registration

CANTERBURY SCIENTIFIC LTD. Registration: 3003982601 View Registration

SHIMA LABORATORIES CO., LTD. Registration: 3003985394 View Registration

GlobalMed Holdings, LLC Registration: 3004009431 View Registration

EPS BIO TECHNOLOGY CORP. Registration: 3004130086 View Registration

TAIDOC TECHNOLOGY CORPORATION Registration: 3004145393 View Registration

OSANG Healthcare CO., LTD. Registration: 3004146366 View Registration

CONE BIOPRODUCTS OF SEGUIN LLC Registration: 3004152597 View Registration

PHC Corporation Registration: 3004167884 View Registration

CAMBRIDGE SENSORS LIMITED Registration: 3004176168 View Registration

BIONIME CORPORATION Registration: 3004183148 View Registration

NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS Registration: 3004193489 View Registration

DiaSorin Deutschland GmbH Registration: 3004434309 View Registration

RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration

Tosoh Hi-Tec, Inc. Registration: 3004529019 View Registration

AGAMATRIX Registration: 3004637226 View Registration

PHADIA US INC. Registration: 3004973408 View Registration

ABBOTT IRELAND DIAGNOSTICS DIVISION Registration: 3005094123 View Registration

ABBOTT LABORATORIES Registration: 3005333358 View Registration

Rosie Connectivity Solutions, Inc. Registration: 3005393828 View Registration

SEJOY BIOMEDICAL CO., LTD. Registration: 3005395953 View Registration

BEIJING GENESEE BIOTECH, INC. Registration: 3005450604 View Registration

TOSOH BIOSCIENCE, INC. Registration: 3005529799 View Registration

I-SENS, INC. Registration: 3005621222 View Registration

FUJIFILM Healthcare Americas Corporation Registration: 3005625991 View Registration

ABBOTT POINT OF CARE CANADA LIMITED Registration: 3005643513 View Registration

VISGENEER, INC. Registration: 3005644014 View Registration

MHC Medical Products Registration: 3005798905 View Registration

CEZANNE SAS Registration: 3005847079 View Registration

OK BIOTECH CO., LTD. Registration: 3005862821 View Registration

Diamond Diagnostics Inc. Registration: 3006198300 View Registration

RR DONNELLEY-SUPPLY CHAIN SOLUTIONS Registration: 3006371704 View Registration

ALLIANCE INTERNATIONAL MEDICAL CO., LTD. Registration: 3006532271 View Registration

DIASYS DIAGNOSTIC SYSTEMS GMBH Registration: 3006644620 View Registration

BIONIME USA CORPORATION Registration: 3006755541 View Registration

BD Rapid Diagnostics (Suzhou) Co. Ltd. Registration: 3006948883 View Registration

LGC Clinical Diagnostics, Inc. Registration: 3007088335 View Registration

Ortho-Clinical Diagnostics Registration: 3007111389 View Registration

EUROIMMUN US INC. Registration: 3007118747 View Registration

FORA CARE INC. Registration: 3007134734 View Registration

Trukera Medical Registration: 3007137761 View Registration

NANOENTEK INC Registration: 3007349751 View Registration

All Medicus Co., Ltd. Registration: 3007363438 View Registration

i-SENS Wonju Factory Registration: 3007382160 View Registration

VERIDIAN HEALTHCARE Registration: 3007499349 View Registration

MICROBIX Registration: 3007652384 View Registration

VitalScientific Registration: 3007662974 View Registration

Flextronics Industrial (Shenzhen) Co., Ltd. Registration: 3007710663 View Registration

BECTON, DICKINSON & CO. Registration: 3007886372 View Registration

TECHNO-PATH MANUFACTURING LTD. Registration: 3008156187 View Registration

ABBOTT IRELAND Registration: 3008344661 View Registration

Telcare, LLC Registration: 3008514395 View Registration

RR Donnelley GTS Poland Sp. z o.o. Registration: 3008606429 View Registration

Cambridge Sensors USA, LLC. Registration: 3008700497 View Registration

I-SENS USA, INC. Registration: 3008780388 View Registration

PRODIGY DIABETES CARE, LLC Registration: 3008789114 View Registration

SD Biosensor, Inc. Registration: 3008959428 View Registration

NANOENTEK INC Registration: 3009092698 View Registration

GL DIABETES CORPORATION Registration: 3009129531 View Registration

UPS SUPPLY CHAIN SOLUTIONS, INC. Registration: 3009171251 View Registration

Agilent Technologies Inc. Registration: 3009189893 View Registration

BIOREX LABS LLC Registration: 3009469260 View Registration

BODITECH MED INC. Registration: 3009491259 View Registration

7051395 CANADA INC DBA HTA DIRECT SOURCING Registration: 3009518015 View Registration

Integra Biotechnical, SA de CV Registration: 3009746061 View Registration

LAKE COUNTY PRESS Registration: 3009901017 View Registration

Bio-Rad Laboratories Inc. Registration: 3010127294 View Registration

BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration

KOVA INTERNATIONAL INC Registration: 3010152370 View Registration

DIAGENODE s.a. Registration: 3010534606 View Registration

MEDIUSA INC. Registration: 3010713600 View Registration

BiometerPlus USA, Inc. Registration: 3010830834 View Registration

NOWDIAGNOSTICS, INC. Registration: 3010864358 View Registration

Microgenics Corporation Registration: 3010939897 View Registration

Ascensia Diabetes Care US Inc. Registration: 3011121740 View Registration

i-SENS Songdo Factory Registration: 3011213605 View Registration

AALTO SCIENTIFIC LTD. Registration: 3011325031 View Registration

ROCHE DIABETES CARE, INC. Registration: 3011393376 View Registration

GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD Registration: 3011420269 View Registration

Nova Biomedical Corporation Registration: 3011979858 View Registration

DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration

Katmai Health Services LLC Registration: 3012104670 View Registration

SPEEDX PTY LTD Registration: 3012113276 View Registration

ASCENSIA DIABETES CARE HOLDINGS AG Registration: 3012118659 View Registration

SD BIOSENSOR, INC. Registration: 3012133212 View Registration

INSTRUMENTATION LABORATORY SPA Registration: 3012348571 View Registration

SG BioScience, INC Registration: 3012422258 View Registration

THE BINDING SITE Registration: 3012471076 View Registration

SANICURE BV Registration: 3012494290 View Registration

Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration

ATSI Logistics Center ApS Registration: 3013059683 View Registration

RR Donnelley Global Turnkey Solutions Registration: 3013160357 View Registration

VIVACHEK BIOTECH (HANGZHOU) CO., LTD Registration: 3013223546 View Registration

ARKRAY Industry West Inc. Registration: 3013472743 View Registration

High Technology, Inc. Registration: 3013660430 View Registration

Quidel Cardiovascular Inc. Registration: 3013982035 View Registration

STS CORPORATION Registration: 3014150341 View Registration

MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 View Registration

PHC Corporation Registration: 3014353045 View Registration

VIDAN DIAGNOSTICS, LLC Registration: 3014353121 View Registration

RANDOX LABORATORIES LIMITED Registration: 3014607865 View Registration

J. Knipper and Company, Inc. Registration: 3014680791 View Registration

GOLDEN SMART HOME TECHNOLOGY CORP. Registration: 3015188281 View Registration

Exel Inc. dba DHL Supply Chain (USA) Registration: 3015347724 View Registration

Polymer Technology Systems Registration: 3015525148 View Registration

HUMAN METABOLOMICS INSTITUTE, INC. Registration: 3015972771 View Registration

KATMAI INTEGRATED SOLUTIONS Registration: 3015997711 View Registration

ABBOTT LABORATORIES Registration: 3016438761 View Registration

PRECISION DIABETES, INC. Registration: 3016698405 View Registration

Changsha Sinocare Inc. Registration: 3016863723 View Registration

PREVOUNCE HEALTH, INC Registration: 3017500903 View Registration

TENOVI CO Registration: 3017520431 View Registration

MAQ-OPS, S. DE R.L. Registration: 3017550662 View Registration

Sekisui Diagnostics, LLC Registration: 3017772438 View Registration

OXILINE LLC Registration: 3018940143 View Registration

OSANG LLC Registration: 3020885868 View Registration

Ortho-Clinical Diagnostics, Inc. Registration: 3021090658 View Registration

Teladoc Health, Inc. - Lewisville Registration: 3021611414 View Registration

BIALEX LAB Registration: 3021841051 View Registration

Remote Smart Health LLC Registration: 3024512705 View Registration

YASEE BIOMEDICAL INC Registration: 3026260647 View Registration

FORT WORTH DIAGNOSTICS LLC Registration: 3027062375 View Registration

I-SENS Songdo Factory 2 Registration: 3030186688 View Registration

BOI(VIETNAM) Company Ltd Registration: 3030978471 View Registration

CARE LIVING DIAGNOSTICS INC Registration: 3031259044 View Registration

BIO-RAD LABORATORIES, INC. Registration: 3032705 View Registration

Laboratorios Scantibodies, S.A. de C.V. Registration: 3033507883 View Registration

Ortho-Clinical Diagnostics, Inc. Registration: 3033751096 View Registration

SUPPLY MAX NY INC Registration: 3033967997 View Registration

INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration

Ascensia Diabetes Care Poland Sp. z o.o. Registration: 3038419886 View Registration

RASIMO SYSTEMS LLC Registration: 3042026207 View Registration

LifeScan U.S. LLC Registration: 3042301847 View Registration

Sekisui Diagnostics P.E.I. Inc. Registration: 8020316 View Registration

Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 View Registration

IMMUNODIAGNOSTIC SYSTEMS LTD. Registration: 8021924 View Registration

Immunotech SAS, a Beckman Coulter company Registration: 8023018 View Registration

SEBIA Registration: 8023024 View Registration

TOSOH CORP. Registration: 8031673 View Registration

AXIS-SHIELD DIAGNOSTICS, LTD. Registration: 8032314 View Registration

Nagase Diagnostics Co., Ltd, Diagnostics Division, Ohito Diagnostics Plant Registration: 8043889 View Registration

WALLAC OY Registration: 8043909 View Registration

Agilent Technologies Denmark ApS Registration: 9610099 View Registration

AIDIAN OY Registration: 9610102 View Registration

ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration

DiaSorin Italia S.p.A. Registration: 9610240 View Registration

ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration

PHADIA AB Registration: 9610566 View Registration

BIOKIT S.A. Registration: 9610746 View Registration

Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration

ARKRAY, INC. Registration: 9611444 View Registration

TOSOH AIA, INC. Registration: 9612316 View Registration

Abbott Diagnostics Technologies AS Registration: 9613069 View Registration

The Binding Site Group Ltd. Registration: 9614373 View Registration

ACON BIOTECH (HANGZHOU) CO., LTD. Registration: 9615507 View Registration

IMMUNODIAGNOSTIC SYSTEMS FRANCE SAS Registration: 9615777 View Registration

Fujirebio Europe N.V. Registration: 9615837 View Registration

TIANJIN EMPECS MEDICAL DEVICE CO., LTD. Registration: 9616530 View Registration

WATERS TECHNOLOGIES IRELAND, LTD. Registration: 9616673 View Registration

APEX BIOTECHNOLOGY CORP. Registration: 9616936 View Registration

EUROTROL B.V. Registration: 9681518 View Registration

TRINITY BIOTECH, PLC Registration: 9681576 View Registration

SENTINEL CH. SPA Registration: 9681753 View Registration

IBL INTERNATIONAL GMBH Registration: 9710337 View Registration

ABBOTT DIABETES CARE LIMITED Registration: 9710492 View Registration

GLOBAL INSTRUMENTATION CORP. Registration: 9710595 View Registration

IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material

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