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

Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality (JMZ) (5) Counter, Cell, Automated (Particle Counter) (GKL) (1)

Premarket Exempt

No Yes

Clear

Advanced Instruments 0 mOsm Calibration Standard - 2mL Ampule - Pkg 10 - 10816068020754 Catalog Number : 3MA000

Device Description : Calibration standards are used to calibrate and/or check the performance of cus Calibration standards are used to calibrate and/or check the performance of customer osmometers.

Device Class : 1

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : JMZ

Prescription Use : No

Device Count : 10

Advanced Instruments 200 mOsm Calibration Standard - 2mL Ampule - Pkg 10 - 10816068020761 Catalog Number : 3MA020

Device Description : Calibration standards are used to calibrate and/or check the performance of cus Calibration standards are used to calibrate and/or check the performance of customer osmometers.

Device Class : 1

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : JMZ

Prescription Use : No

Device Count : 10

Advanced Instruments 400 mOsm Calibration Standard - 2mL Ampule - Pkg 10 - 10816068020778 Catalog Number : 3MA040

Device Description : Calibration standards are used to calibrate and/or check the performance of cus Calibration standards are used to calibrate and/or check the performance of customer osmometers.

Device Class : 1

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : JMZ

Prescription Use : No

Device Count : 10

Advanced Instruments 1000 mOsm Calibration Standard - 2mL Ampule - Pkg 10 - 10816068020785 Catalog Number : 3MA100

Device Description : Calibration standards are used to calibrate and/or check the performance of cus Calibration standards are used to calibrate and/or check the performance of customer osmometers.

Device Class : 1

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : JMZ

Prescription Use : No

Device Count : 10

Advanced Instruments 4000 mOsm Calibration Std - 2mL Ampule - Pkg 10 - 10816068020990 Catalog Number : 3MA400

Device Description : Advanced Instruments 4000 mOsm Calibration Std - 2mL Ampule - Pkg 10

Device Class : 1

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : JMZ

Prescription Use : No

Device Count : 10

Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays - 20816068020201 Catalog Number : 111010

Device Description : For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Test Cartridge Kit - For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains 200 test cartridges.

Device Class :

Duns Number: 125006353

Premarket Exempt : No

Product Code : GKL

Prescription Use : Yes

Device Count : 200

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