RAPID DIAGNOSTICS 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

ENZYME IMMUNOASSAY, OPIATES (DJG) (4) ENZYME IMMUNOASSAY, CANNABINOIDS (LDJ) (1) ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES (DIO) (1) ENZYME IMMUNOASSAY, AMPHETAMINE (DKZ) (1) Enzyme immunoassay, benzodiazepine (JXM) (1) THIN LAYER CHROMATOGRAPHY, BARBITURATE (DKX) (1) ENZYME IMMUNOASSAY, METHADONE (DJR) (1)

Premarket Exempt

No Yes

Clear

RAPID DIAGNOSTICS COCAINE TEST STRIP KIT (50) - 00817830020159 Catalog Number : 07RD8007

Device Description : COCAINE TEST STRIP KIT (50)

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS MARIJUANA (THC) TEST STRIP KIT (50) - 00817830020166 Catalog Number : 07RD8009

Device Description : MARIJUANA (THC) TEST STRIP KIT (50)

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : LDJ

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS OPIATES TEST STRIP KIT (50) - 00817830020173 Catalog Number : 07RD8011

Device Description : OPIATES TEST STRIP KIT (50)

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS AMPHETAMINE TEST STRIP KIT (50) - 00817830020180 Catalog Number : 07RD8013

Device Description : AMPHETAMINE TEST STRIP KIT (50)

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS BARBITURATE TEST STRIP KIT (50) - 00817830020197 Catalog Number : 07RD8015

Device Description : BARBITURATE TEST STRIP KIT (50)

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DKX

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS BENZODIAZEPINE TEST STRIP KIT (50) - 00817830020203 Catalog Number : 07RD8017

Device Description : BENZODIAZEPINE TEST STRIP KIT (50)

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS METHADONE TEST STRIP KIT (50) - 00817830020210 Catalog Number : 07RD8019

Device Description : METHADONE TEST STRIP KIT (50)

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DJR

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS PCP TEST STRIP KIT (50) - 00817830020227 Catalog Number : 07RD8021

Device Description : PCP TEST STRIP KIT (50)

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS OPI/MOR 2000 TEST STRIP KIT (50) - 00817830020234 Catalog Number : 07RD8039

Device Description : OPI/MOR 2000 TEST STRIP KIT (50)

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS OXYCODONE TEST STRIP KIT (50) - 00817830020241 Catalog Number : 07RD8100

Device Description : OXYCODONE TEST STRIP KIT (50)

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

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