ADVANCED INSTRUMENTS, INC.

Address:6800 NW 77TH COURT,Miami,FL,33166,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Counter, Cell, Automated (Particle Counter) (GKL) (4) Mixture, Hematology Quality Control (JPK) (3) Diazo Colorimetry, Bilirubin (CIG) (2) Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality (JMZ) (1)

Premarket Exempt

No Yes

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Advanced Instruments BR2 Sulfanilic Acid - 00816068020115 Catalog Number :

Device Description : 25mL bottle of Sulfanilic Acid

Device Class : 2

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : CIG

Prescription Use : Yes

Device Count : 1

Advanced Instruments BR2 Hydrochloric Acid - 00816068020122 Catalog Number :

Device Description : 25mL bottle of Hydrochloric Acid

Device Class : 2

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : CIG

Prescription Use : Yes

Device Count : 1

Advanced Instruments GloCyte® Automated Cell Counter System - 00816068020139 Catalog Number : GloCyte

Device Description : For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Automated Cell Count For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients. Includes GloCyte instrument, computer, vacuum station, barcode reader, sample preparation tray, pipettes, and startup kit.

Device Class : 2

Duns Number: 125006353

Premarket Exempt : No

Product Code : GKL

Prescription Use : Yes

Device Count : 1

Advanced Instruments GloCyte® Instrument Assembly - 00816068020146 Catalog Number : 111000

Device Description : For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Instrument has been For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Instrument has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Utilizes fluorescence-based technology to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid.

Device Class : 2

Duns Number: 125006353

Premarket Exempt : No

Product Code : GKL

Prescription Use : Yes

Device Count : 1

Advanced Instruments GloCyte® Vacuum Preparation Station Assembly - 00816068020153 Catalog Number : 111076

Device Description : For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Vacuum Station has b For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Vacuum Station has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Accelerates the capturing of stained cells on the test cartridge.

Device Class : 2

Duns Number: 125006353

Premarket Exempt : No

Product Code : GKL

Prescription Use : Yes

Device Count : 1

Advanced Instruments GloCyte® Low Level Control Vial (Single) - 00816068020184 Catalog Number :

Device Description : 3 mL vial of Low Level Control

Device Class : 2

Duns Number: 125006353

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Advanced Instruments GloCyte® High Level Control Vial (Single) - 00816068020191 Catalog Number :

Device Description : 3 mL vial of High Level Control

Device Class : 2

Duns Number: 125006353

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Advanced Instruments GloCyte® Controls Kit - 00816068020238 Catalog Number : 111013

Device Description : For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Low and High Level Co For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Low and High Level Control Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains one 3mL vial of Low Level Control and one 3mL vial of High Level Control.

Device Class : 2

Duns Number: 125006353

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Advanced Instruments GloCyte® Count Template Cartridge - 00816068020245 Catalog Number : 111153

Device Description : For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Count Template Cartr For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Count Template Cartridge has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. The Count Template Cartridge is a service tool used to check the performance of the GloCyte System.

Device Class : 2

Duns Number: 125006353

Premarket Exempt : No

Product Code : GKL

Prescription Use : Yes

Device Count : 1

Advanced Instruments Renol 2 Level Urine Osmolality Control - 3mL Vial - Pkg 8 - 00816068020290 Catalog Number : 3LA085

Device Description : Renol urine osmolality controls are intended for use in evaluating the performan Renol urine osmolality controls are intended for use in evaluating the performance of customer osmometers. Controls may be used daily to monitor the precision of the testing procedure for osmolality, and to conduct laboratory proficiency testing. Renol urine controls are formulated to mimic reportable ranges (low-to-high levels) for urine.

Device Class : 1

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : JMZ

Prescription Use : No

Device Count : 1

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