Medtest Dx, 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

Multi-Analyte Controls, All Kinds (Assayed) (JJY) (4) Analyzer, Chemistry, Micro, For Clinical Use (JJF) (3) Bromcresol Green Dye-Binding, Albumin (CIX) (2) Kinetic Method, Gamma-Glutamyl Transpeptidase (JQB) (1)

Premarket Exempt

No Yes

Clear

Pointe Scientific, Inc. GGT - 00811727014740 Catalog Number : HG959-1400

Device Description : Gamma glutamyl transferase Reagent is for the quantitative kinetic determination

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : JQB

Prescription Use : Yes

Device Count : 1

Direct Lipid Control Set - 00817439020000 Catalog Number : 3000

Device Description : This product is intended for in-vitro use only, in the quality control of Direct

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Direct Lipid Control L1 - 00817439020017 Catalog Number : 3001

Device Description : This product is intended for in-vitro use only, in the quality control of Direct

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Direct Lipid Control L2 - 00817439020024 Catalog Number : 3002

Device Description : This product is intended for in-vitro use only, in the quality control of Direct

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Direct Lipid Control L3 - 00817439020031 Catalog Number : 3003

Device Description : This product is intended for in-vitro use only, in the quality control of Direct

Device Class : 1

Duns Number: 070371210

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Wash Concentrate 1 - 00817439020062 Catalog Number : 03W500

Device Description : For use as a cleaning solution on automated analyzers. 6 x 25 ml

Device Class : 1

Duns Number: 070371210

Premarket Exempt : Yes

Product Code : JJF

Prescription Use : Yes

Device Count : 1

Wash Concentrate 2 - 00817439020079 Catalog Number : 09W500

Device Description : For use as a cleaning solution on automated analyzers. 6 x 25 ml

Device Class : 1

Duns Number: 070371210

Premarket Exempt : Yes

Product Code : JJF

Prescription Use : Yes

Device Count : 1

Wash Concentrate 3 - 00817439020086 Catalog Number : 10W500

Device Description : This product will be used as a concentrated wash solution on automated analyzers

Device Class : 1

Duns Number: 070371210

Premarket Exempt : Yes

Product Code : JJF

Prescription Use : Yes

Device Count : 1

Albumin / BS480 - 00817439020093 Catalog Number : ALB480

Device Description : For the quantitative determination of Albumin in serum using the Mindray BS-480

Device Class : 2

Duns Number: 070371210

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

Albumin - 00817439020109 Catalog Number : ALB505

Device Description : For the quantitative in vitro determination of Albumin in serum and plasma on th

Device Class : 2

Duns Number: 070371210

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

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