Address:Yousuien-nai,Kamigyo-ku Kyoto,JP
Device Description : he AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System contai he AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathological Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Device Class : 1
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Dry Chemistry Analyzer IVD, semi-automated
Device Class : 2
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Sterile Single-Use Pen Needle samples. Intended to be used with a pen injector Sterile Single-Use Pen Needle samples. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No
Device Description : Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of drugs.
Device Class :
Duns Number: 008171162
Premarket Exempt : No
Prescription Use : No