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

GlucoLin is an assayed quality control material for professional use to verify the performance characteristics of HemoCue® Glucose systems. Glucolin is intended for the quantitative determination of glucose.A box of GlucoLin contains 5 levels of control material:GlucoLin XLow: 08718734961352GlucoLin Low: 08718734961369GlucoLin Normal: 08718734961376GlucoLin High: 08718734961383GlucoLin XHigh: 08718734961390

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.

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).

Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems.

Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems.

Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Immunoassay Kit

The Celiac Disease IgG Calibrators include antibodies to tTG and DGP.1. Aptiva Celiac IgG Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. 2. Aptiva Celiac IgG Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives.3. Aptiva Celiac IgG Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives.

The Celiac Disease IgG Controls include antibodies to tTG and DGP.1. Aptiva Celiac IgG 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 IgG Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives.

1. Aptiva Celiac Disease IgA Reagent Cartridge contains reagents to process 250 samples.a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives.c. PE Tracer IgA – PE labeled anti-human IgA antibody, containing buffer, protein stabilizers and preservative.d. Rehydration Buffer - containing protein stabilizers and preservatives

The Celiac Disease IgA Calibrators include antibodies to tTG and DGP.1. Aptiva Celiac IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. 2. Aptiva Celiac IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives.3. Aptiva Celiac IgA Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives.

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.

Avox-4 CO-Oximeter Control, Level 1

Avox-4 CO-Oximeter Control, Level 2

Avox-4 CO-Oximeter Control, Level 3

Avox-4 CO-Oximeter Control Level 1, Level 2 and Level 3

1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. HemosIL Acustar ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives.

GEM Premier ChemSTAT Analyzer

The iPeak® reader 4,3” Lateral Flow Reader (SW Version 3.x) 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.

HCG strips - pregnancy test strips

HCG strips - pregnancy test strips - REGISTRATION NUMBER HCG STRIP: 21 CFR 862.1155

Reagent Production Instrument