RAPID DIAGNOSTICS 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

ENZYME IMMUNOASSAY, OPIATES (DJG) (4) Thin layer chromatography, methamphetamine (DJC) (2) ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES (DIO) (1) ENZYME IMMUNOASSAY, METHADONE (DJR) (1) Enzyme immunoassay, benzodiazepine (JXM) (1) THIN LAYER CHROMATOGRAPHY, BARBITURATE (DKX) (1)

Premarket Exempt

No Yes

Clear

RAPID DIAGNOSTICS M-AMPHAMPHETAMINE TEST STRIP - 00817830020029 Catalog Number : 07RD7005

Device Description : M-AMPHAMPHETAMINE TEST STRIP

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DJC

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS COCAINE TEST STRIP - 00817830020036 Catalog Number : 07RD7007

Device Description : COCAINE TEST STRIP

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS OPIATES TEST STRIP - 00817830020050 Catalog Number : 07RD7011

Device Description : OPIATES TEST STRIP

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS BARBITURATE TEST STRIP - 00817830020074 Catalog Number : 07RD7015

Device Description : BARBITURATE TEST STRIP

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DKX

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS BENZODIAZEPINE TEST STRIP - 00817830020081 Catalog Number : 07RD7017

Device Description : BENZODIAZEPINE TEST STRIP

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS METHADONE TEST STRIP - 00817830020098 Catalog Number : 07RD7019

Device Description : METHADONE TEST STRIP

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DJR

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS PCP TEST STRIP - 00817830020104 Catalog Number : 07RD7021

Device Description : PCP TEST STRIP

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS OPI/MOR TEST STRIP - 2000 - 00817830020111 Catalog Number : 07RD7039

Device Description : OPI/MOR TEST STRIP - 2000

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS BUPRENORPHINE TEST STRIP - 00817830020135 Catalog Number : 07RD7105

Device Description : BUPRENORPHINE TEST STRIP

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

RAPID DIAGNOSTICS M-AMPHAMPHETAMINE TEST STRIP KIT (50) - 00817830020142 Catalog Number : 07RD8005

Device Description : M-AMPHAMPHETAMINE TEST STRIP KIT (50)

Device Class : 2

Duns Number: 008028248

Premarket Exempt : No

Product Code : DJC

Prescription Use : Yes

Device Count : 1

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