GENCHEM INC

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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) (4) ELECTRODE, ION SPECIFIC, CALCIUM (JFP) (2) ELECTRODE, ION SPECIFIC, POTASSIUM (CEM) (2) ELECTRODE, ION SPECIFIC, SODIUM (JGS) (2) ELECTRODE, ION-SPECIFIC, CHLORIDE (CGZ) (2) GLUCOSE OXIDASE, GLUCOSE (CGA) (2) PH RATE MEASUREMENT, CARBON-DIOXIDE (JFL) (2) HEXOKINASE, GLUCOSE (CFR) (1) BIURET (COLORIMETRIC), TOTAL PROTEIN (CEK) (1)

Premarket Exempt

Clear

GENCHEM™ Direct Bilirubin Reagent - 00851445007204 Catalog Number : GEN-DBILI R2

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

GENCHEM™ Glucose Oxidase Reagent - 00851445007211 Catalog Number : GEN-GLU3

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : CGA

Prescription Use : Yes

Device Count : 1

GENCHEM™ Glucose Oxidase Reagent - 00851445007228 Catalog Number : GEN-GLU LX

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : CGA

Prescription Use : Yes

Device Count : 1

GENCHEM™ Glucose Reagent - 00851445007235 Catalog Number : GEN-GLU4

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : CFR

Prescription Use : Yes

Device Count : 1

GENCHEM™ ISE Electrolyte Buffer - 00851445007242 Catalog Number : GEN-ISE BUFFER

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : CGZ, CEM, JFP, JFL, JGS

Prescription Use : Yes

Device Count : 1

GENCHEM™ ISE Electrolyte Reference - 00851445007259 Catalog Number : GEN-ISE REFERENCE

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : JFL, CGZ, JFP, CEM, JGS

Prescription Use : Yes

Device Count : 1

GENCHEM™ Total Bilirubin Reagent - 00851445007266 Catalog Number : GEN-TBILI R1

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

GENCHEM™ Total Bilirubin Reagent - 00851445007273 Catalog Number : GEN-TBILI R2

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

GENCHEM™ Total Bilirubin Reagent - 00851445007280 Catalog Number : GEN-TBILI R3

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

GENCHEM™ Total Protein Reagent - 00851445007297 Catalog Number : GEN-TP

Device Description : 10/17/2022

Device Class : 2

Duns Number: 193856866

Premarket Exempt : No

Product Code : CEK

Prescription Use : Yes

Device Count : 1

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