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

Diazo Colorimetry, Bilirubin (CIG) (8) Counter, Cell, Automated (Particle Counter) (GKL) (2)

Premarket Exempt

No Yes

Clear

Advanced Instruments GloCyte® Pipette, 30µL Fixed Volume - 00816068020009 Catalog Number : 806054

Device Description : For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Pipette, 30µL Fixed For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Pipette, 30µL Fixed Volume has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Used for aspirating and dispensing sample and reagents.

Device Class : 2

Duns Number: 125006353

Premarket Exempt : No

Product Code : GKL

Prescription Use : Yes

Device Count : 1

Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume - 00816068020016 Catalog Number : 806053

Device Description : For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Pipette, 10µL Fixed For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Used for aspirating and dispensing sample and reagents.

Device Class : 2

Duns Number: 125006353

Premarket Exempt : No

Product Code : GKL

Prescription Use : Yes

Device Count : 1

Advanced Instruments BR2 Disposable Cuvettes - 00816068020023 Catalog Number : B2A800

Device Class : 2

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : CIG

Prescription Use : Yes

Device Count : 1

Advanced Instruments BR2 Total Bilirubin Test Kit, Reagents, and Cuvettes - 00816068020030 Catalog Number : B2A101

Device Description : For In Vitro Diagnostic Use. Advanced Instruments Total Bilirubin Test Kit has For In Vitro Diagnostic Use. Advanced Instruments Total Bilirubin Test Kit has been developed for use exclusively with the Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) bilirubin in neonatal serum or plasma. Includes four 30mL bottles of Diluent, one 3mL bottle of 5mg/dL Bilirubin Equivalent, one bottle of 20mg/dL 3mL Bilirubin Equivalent, and 100 Cuvettes.

Device Class : 2

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : CIG

Prescription Use : Yes

Device Count : 1

Advanced Instruments BR2 Total and Direct Test Kit, Reagents, and Cuvettes - 00816068020047 Catalog Number : B2A102

Device Description : For In Vitro Diagnostic Use. Advanced Instruments Total and Direct Bilirubin Te For In Vitro Diagnostic Use. Advanced Instruments Total and Direct Bilirubin Test Kit has been developed for use exclusively with the Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) and DIRECT (DBR) bilirubin in neonatal serum or plasma. Includes four 30mL bottles of Diluent, one 3mL bottle of 5mg/dL Bilirubin Equivalent, one bottle of 20mg/dL 3mL Bilirubin Equivalent, one 25mL bottle of Sulfanilic Acid Solution, one 25mL bottle of 0.2N Hydrochloric Acid, one 50mg Sodium Nitrite Tablet and 100 Cuvettes.

Device Class : 2

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : CIG

Prescription Use : Yes

Device Count : 1

Advanced Instruments BR2 Bilirubin Stat-Analyzer - 00816068020054 Catalog Number : BR2

Device Description : For In Vitro Diagnostic Use. Advanced Instruments BR2 Bilirubin Stat-Analyzer P For In Vitro Diagnostic Use. Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) and DIRECT (DBR) bilirubin in neonatal serum or plasma.

Device Class : 2

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : CIG

Prescription Use : Yes

Device Count : 1

Advanced Instruments BR2 Sample Diluent - 00816068020078 Catalog Number :

Device Description : 30mL bottle of Diluent

Device Class : 2

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : CIG

Prescription Use : Yes

Device Count : 1

Advanced Instruments BR2 20 mg/dL Bilirubin Equivalent Solution - 00816068020085 Catalog Number :

Device Description : 3mL bottle of 20 mg/dL Bilirubin Equivalent Solution

Device Class : 2

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : CIG

Prescription Use : Yes

Device Count : 1

Advanced Instruments BR2 5mg/dL Bilirubin Equivalent Solution - 00816068020092 Catalog Number :

Device Description : 3mL bottle of 5 mg/dL Bilirubin Equivalent Solution

Device Class : 2

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : CIG

Prescription Use : Yes

Device Count : 1

Advanced Instruments BR2 Sodium Nitrite - 00816068020108 Catalog Number :

Device Description : 50mg Sodium Nitrite Tablet

Device Class : 2

Duns Number: 125006353

Premarket Exempt : Yes

Product Code : CIG

Prescription Use : Yes

Device Count : 1

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