Instant Tech Subsidiary Acquisition

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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

Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (10) Enzyme Immunoassay, Amphetamine (DKZ) (10) Gas Chromatography, Methamphetamine (LAF) (10) Enzyme Immunoassay, Opiates (DJG) (10) Enzyme Immunoassay, Cannabinoids (LDJ) (9) Enzyme Immunoassay, Benzodiazepine (JXM) (9) Enzyme Immunoassay, Phencyclidine (LCM) (5) Enzyme Immunoassay, Methadone (DJR) (4) Enzyme Immunoassay, Barbiturate (DIS) (4) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (2)

Premarket Exempt

Clear

U-Screen - 00858998006104 Catalog Number : USSCupA-12BUP300

Device Description : U-Screen Squared Integrated Cup with Adulterants(CR,SG,PH) 12 Panel Drug Screen U-Screen Squared Integrated Cup with Adulterants(CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/BUP/MDMA/MTD/OXY)

Device Class : 2

Duns Number: 080317182

Premarket Exempt : No

Product Code : DJG, DIO, LDJ, DJR, DIS, JXM, LCM, LAF, DKZ

Prescription Use : Yes

Device Count : 1

U-Screen - 00858998006111 Catalog Number : USSCupA-12BUP300CLIA

Device Description : U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/BUP/MDMA/MTD/OXY)

Device Class : 2

Duns Number: 080317182

Premarket Exempt : No

Product Code : DJR, DIS, JXM, LCM, LAF, DKZ, DJG, DIO, LDJ

Prescription Use : Yes

Device Count : 1

U-Screen - 00858998006128 Catalog Number : USSCupA-12CLIA

Device Class : 2

Duns Number: 080317182

Premarket Exempt : No

Product Code : LFG, DJR, LCM, JXM, DIS, LAF, DKZ, DJG, DIO, LDJ

Prescription Use : Yes

Device Count : 1

U-Screen - 00858998006135 Catalog Number : USSCupA-12NTCLIA

Device Description : U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Pane U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (COC/MOP/AMP/MET/BAR/BZO/BUP/PCP/MDMA/MTD/OXY/TCA)

Device Class : 2

Duns Number: 080317182

Premarket Exempt : No

Product Code : LFG, DJR, LCM, JXM, DIS, LAF, DKZ, DJG, DIO

Prescription Use : Yes

Device Count : 1

U-Screen - 00858998006142 Catalog Number : USSCupA-5M

Device Description : U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 5 Panel Drug Screen U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)

Device Class : 2

Duns Number: 080317182

Premarket Exempt : No

Product Code : LAF, DKZ, DJG, DIO, LDJ

Prescription Use : Yes

Device Count : 1

U-Screen - 00858998006159 Catalog Number : USSCupA-6MB

Device Description : U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/BZO)

Device Class : 2

Duns Number: 080317182

Premarket Exempt : No

Product Code : JXM, LAF, DKZ, DJG, DIO, LDJ

Prescription Use : Yes

Device Count : 1

U-Screen - 00858998006166 Catalog Number : USSCupA-7BP CM

Device Description : U-Screen Squared Integrated Cup with Adulterants 7 Panel Drug Screen (CR,SG,OX) U-Screen Squared Integrated Cup with Adulterants 7 Panel Drug Screen (CR,SG,OX) for (THC/COC/OPI2000/AMP/MET/PCP/BZO)

Device Class : 2

Duns Number: 080317182

Premarket Exempt : No

Product Code : JXM, LCM, LAF, DKZ, DJG, DIO, LDJ

Prescription Use : Yes

Device Count : 1

U-Screen - 00858998006173 Catalog Number : USSCupA-7MOB

Device Description : U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BZO/OXY)

Device Class : 2

Duns Number: 080317182

Premarket Exempt : No

Product Code : JXM, LAF, DKZ, DJG, DIO, LDJ

Prescription Use : Yes

Device Count : 1

U-Screen - 00858998006180 Catalog Number : USSCupA-7MOBCLIA

Device Description : U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BZO/OXY)

Device Class : 2

Duns Number: 080317182

Premarket Exempt : No

Product Code : JXM, LAF, DKZ, DJG, DIO, LDJ

Prescription Use : Yes

Device Count : 1

U-Screen - 00858998006197 Catalog Number : USSDip-6MB

Device Description : 6-Panel UScreen Dip Drug Screen (THC/COC/OPI2000/AMP/MET/BZO)

Device Class : 2

Duns Number: 080317182

Premarket Exempt : No

Product Code : JXM, LAF, DKZ, DJG, DIO, LDJ

Prescription Use : Yes

Device Count : 1

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