ELITech Clinical Systems SAS

all lots

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Nationwide Distribution

Envoy 500 system includes the following product reference numbers and names: || 55345 ENVOY 500 Glucose || 55450 ENVOY 500 URIC ACID REAGENT KIT || 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, || 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, || 55335 ENVOY 500 CREATININE REAGENT KIT || 55301 ENVOY 500 HDL CHOLESTEROL REAGENT || 55310 ENVOY 500 LDL CHOLESTEROL REAGENT KIT

all lots

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Nationwide Distribution

ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. || The following product reference numbers and names: || GPSL-025O: Glucose PAP SL || AUML-0250: URIC ACID MONO SL || CHSL-0250: CHOLESTEROL SL, || TGML-0250: TRIGLYCERIDES SL, || CRSL-0250: CREATININE PAP SL || HDLL-0230: CHOLESTEROL HDL SL 2G || LDLL-0230: CHOLESTEROL LDL SL 2G

all lots

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Nationwide Distribution

Eon 300 system includes the following product reference numbers and names: || Reference no. 79345 Glucose (GPSL) || Reference no. 79450 Uric acid (AUVD) || Reference no. 79435 Triglycerides (TGML) || Reference no. 79295 Cholesterol (CHVD) || Reference no. 79301 Cholesterol HDL (HDLL) || Reference no. 79310 Cholesterol, LDL (LDLL)

all lots

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Nationwide Distribution

Eon 100 system included the following product reference numbers and names: || Reference no. 77345- Glucose (GPSL) || Reference no. 77450- Uric acid (AUVD) || Reference no. 77435- Triglycerides (TGML) || Reference no. 77295- Cholesterol (CHVD) || Reference no. 77301- Cholesterol HDL (HDLL) || Reference no. 77310- Cholesterol, LDL (LDLL)

Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015; Lot 4074, Expiration date 11/2015;

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution

ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. || Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. || Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.