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Clinical Chemistry

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Name
Company Name
Description
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iProven
Sevenground Trading B.V.
FK-127A contains 50 ovulation test and 20 pregnancy tests.
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iProven
Sevenground Trading B.V.
FMH-139 is a One Step HCG Urine Pregnancy Test
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iProven
Sevenground Trading B.V.
FMH-139 is a One Step HCG Urine Pregnancy Test
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iProven
Sevenground Trading B.V.
FMH-139 is a One Step HCG Urine Pregnancy Test
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iProvèn
Masena Invest B.V.
Box with five midstream pregnancy tests
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iProvèn
Masena Invest B.V.
Box with three midstream pregnancy tests
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iProvèn
Masena Invest B.V.
Fertility KIT with 30 teststrips
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iProvèn
Masena Invest B.V.
Box with 35 ovulation teststrips
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iProvèn
Masena Invest B.V.
Box with 50 ovulation teststrips
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iProvèn
Masena Invest B.V.
Box with 30 pregnancy teststrips
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iProvèn
Masena Invest B.V.
Fertility KIT with 70 teststrips
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iProvèn
Masena Invest B.V.
Box with 35 ovulation teststrips
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iProvèn
Masena Invest B.V.
Box with 50 ovulation teststrips
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iProvèn
Masena Invest B.V.
Box with 30 pregnancy teststrips
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iProvèn
Masena Invest B.V.
Box with 25 ovulation teststrips and 5 pregnancy teststrips
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iProvèn
Masena Invest B.V.
HCG strips - pregnancy test strips - REGISTRATION NUMBER HCG STRIP: 21 CFR 862.1155
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iProvèn
Masena Invest B.V.
HCG strips - pregnancy test strips
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Future Diagnostics
Future Diagnostics Solutions B.V.
Immunoassay Kit
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RPI
Mechatronics USA LLC
Reagent Production Instrument
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CueSee® VeriSTAT QC
Eurotrol B.V.
CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
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CueSee® VeriSTAT QC
Eurotrol B.V.
CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
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CueSee® VeriSTAT QC
Eurotrol B.V.
CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
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CueSee® VeriSTAT LVM
Eurotrol B.V.
CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.A box of CueSee® VeriSTAT LVM contains 5 levels of control material:CueSee® VeriSTAT LVM Level 1 - 08718734961413CueSee® VeriSTAT LVM Level 2 - 08718734961420CueSee® VeriSTAT LVM Level 3 - 08718734961437CueSee® VeriSTAT LVM Level 4 - 08718734961444CueSee® VeriSTAT LVM Level 5 - 08718734961451
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GlucoLin
Eurotrol B.V.
GlucoLin is an assayed glucose control intended for professional use in the verification of the linearity of the HemoCue® Glucose systems.A box of GlucoLin contains 5 levels of control material:GlucoLin XLow: 08718734961352GlucoLin Low: 08718734961369GlucoLin Normal: 08718734961376GlucoLin High: 08718734961383GlucoLin XHigh: 08718734961390
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CueSee® Hyperbaric X-High
Eurotrol B.V.
CueSee® Hyperbaric is an assayed, quality control material for professional use in the verification of the precision and accuracy of the critically high pO2 value range of many blood gas analyzers.
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Eurotrol GlucoTrol-AQ
Eurotrol B.V.
Eurotrol GlucoTrol-AQ is an assayed glucose control intended for professional use in the verification of the precision and accuracy of the HemoCue Glucose 201 analyzer.A box of Eurotrol GlucoTrol-AQ contains 2 levels of control material:GlucoTrol-AQ Low (1): 08718734961536GlucoTrol-AQ High (3): 08718734961543
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Eurotrol
Eurotrol B.V.
Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level.It is a convenience kit for the purposes of UDI compliance because it contains 5 different levels that are packaged together for the convenience of the user and intended to remain packaged together and not replaced, substituted, repackaged, sterilized or otherwise processed or modified before being used by an end user. Therefore, the label of each individual vial within the container is not required to bear a UDI,provided that a UDI is available on the label affixed to the immediate container of the kit.
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Eurotrol
Eurotrol B.V.
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Eurotrol
Eurotrol B.V.
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Eurotrol
Eurotrol B.V.
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Eurotrol® epoc® Calibration Verification Fluids
Eurotrol B.V.
Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol® epoc® Calibration Verification Fluids is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.
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Eurotrol epoc GAS-ISE Metabolites
Eurotrol B.V.
Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 6 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.
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Eurotrol epoc GAS-ISE Metabolites
Eurotrol B.V.
Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 3 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.
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Eurotrol epoc GAS-ISE Metabolites
Eurotrol B.V.
Eurotrol epoc® GAS-ISE Metabolites - Level 2 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 2 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.
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Eurotrol epoc GAS-ISE Metabolites
Eurotrol B.V.
Eurotrol epoc® GAS-ISE Metabolites - Level 1 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 1 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.
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CueSee® Hypoxic
Eurotrol B.V.
CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers’ performance of Oxygen partial pressure (pO2).
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Eurotrol AlbuTrol
Eurotrol B.V.
Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin.
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Eurotrol AlbuTrol
Eurotrol B.V.
Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin.
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Eurotrol GlucoTrol-NG
Eurotrol B.V.
Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems.
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Eurotrol GlucoTrol-NG
Eurotrol B.V.
Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems.
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Eurotrol GlucoTrol-NG
Eurotrol B.V.
Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems.
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"iPeak® reader 4,3"" Lateral Flow Reader"
IUL SA
The iPeak® reader 4,3” Lateral Flow Reader (SW Version 3.0) is an instrument specifically to be used to provide quantitative, semi-quantitative, and/or qualitative in-vitro determination of photometric immunochromatographic test defined and marketed by IUL’ partners. The iPeak® reader 4,3” is intended to be used only in combination with lateral flow (LF) tests indicated for use with the iPeak® reader 4,3”, and only for applications that are described in the respective handbooks of our reader associates.
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40MM BOROSILICATE VESSEL
BIOTECHNOLOGY INSTITUTE SL
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30MM BOROSILICATE VESSEL
BIOTECHNOLOGY INSTITUTE SL
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ENDORET SYSTEM V CENTRIFUGE
BIOTECHNOLOGY INSTITUTE SL
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ENDORET® PLASMATERM H OVEN
BIOTECHNOLOGY INSTITUTE SL
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ENDORET® TEST-TUBE RACK WITH COVER FOR TRANSPORT
BIOTECHNOLOGY INSTITUTE SL
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ENDORET® TEST-TUBE RACK FOR 9 ML TUBES
BIOTECHNOLOGY INSTITUTE SL
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RECIPIENT FOR GRAFT Ø50 mm
BIOTECHNOLOGY INSTITUTE SL
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Aptiva® Celiac Disease IgA Controls
INOVA DIAGNOSTICS, INC.
The Celiac Disease IgA Controls include antibodies to tTG and DGP1. Aptiva Celiac IgA Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives.2. Aptiva Celiac IgA Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives.