GENCHEM INC

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Filters

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

CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (3) ALKALINE PICRATE, COLORIMETRY, CREATININE (CGX) (2) NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES (CGS) (2) PH RATE MEASUREMENT, CARBON-DIOXIDE (JFL) (2) DIAZO COLORIMETRY, BILIRUBIN (CIG) (1)

Premarket Exempt

Clear

GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 1 - 00851445007105 Catalog Number : GEN-CAL 1

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 2 - 00851445007112 Catalog Number : GEN-CAL 2

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 3 - 00851445007129 Catalog Number : GEN-CAL 3

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

GENCHEM™ CK-NAC Reagent - 00851445007136 Catalog Number : GEN-CK R1

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : CGS

Prescription Use : Yes

Device Count : 1

GENCHEM™ CK-NAC Reagent - 00851445007143 Catalog Number : GEN-CK R2

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : CGS

Prescription Use : Yes

Device Count : 1

GENCHEM™ CO2 Acid Reagent - 00851445007150 Catalog Number : GEN-CO2ACID

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : JFL

Prescription Use : Yes

Device Count : 1

GENCHEM™ CO2 Acid Reagent - 00851445007167 Catalog Number : GEN-CO2ALK

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : JFL

Prescription Use : Yes

Device Count : 1

GENCHEM™ Creatinine Test Reagent - 00851445007174 Catalog Number : GEN-CREA R1(Base)

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : CGX

Prescription Use : Yes

Device Count : 1

GENCHEM™ Creatinine Test Reagent - 00851445007181 Catalog Number : GEN-CREA R2(Acid)

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : CGX

Prescription Use : Yes

Device Count : 1

GENCHEM™ Direct Bilirubin Reagent - 00851445007198 Catalog Number : GEN-DBILI R1

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

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