SPEEDY SOLUTIONS LLC

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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

Thin Layer Chromatography, Methamphetamine (DJC) (2) Enzyme Immunoassay, Barbiturate (DIS) (1) Enzyme Immunoassay, Benzodiazepine (JXM) (1) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (1) Enzyme Immunoassay, Methadone (DJR) (1) Enzyme Immunoassay, Amphetamine (DKZ) (1) Enzyme Immunoassay, Phencyclidine (LCM) (1) Gas Chromatography, Methamphetamine (LAF) (1) Reagents, Test, Tetrahydrocannabinol (DKE) (1) Enzyme Immunoassay, Opiates (DJG) (1)

Premarket Exempt

Clear

Speedy Tests - 10866415000311 Catalog Number : STDIPMA-25

Device Description : Speedy Tests DOA Single Test Dipcard, 25Pcs/BoxmAMP

Device Class :

Duns Number: 080428145

Premarket Exempt : No

Product Code : DJC

Prescription Use : Yes

Device Count : 25

Speedy Tests - 10866415000328 Catalog Number : STDIPOP-25

Device Description : Speedy Tests DOA Single Test Dipcard, 25Pcs/BoxOPI

Device Class :

Duns Number: 080428145

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 25

Speedy Tests - 10866415000335 Catalog Number : STDIP3104

Device Description : Speedy Tests DOA 10 in 1 Test Dipcard, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC

Device Class :

Duns Number: 080428145

Premarket Exempt : No

Product Code : DKE, LCM, DJR, LAF, DIO, JXM, DIS, DKZ, DJC

Prescription Use : Yes

Device Count : 25

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