MEDICAL DISTRIBUTION GROUP INC

Address:6771 Whitfield Industrial Ave Unit A,Sarasota,FL,34243,US

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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, Benzodiazepine (JXM) (10) Enzyme Immunoassay, Opiates (DJG) (10) Enzyme Immunoassay, Amphetamine (DKZ) (10) Enzyme Immunoassay, Cannabinoids (LDJ) (10) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (10) Thin Layer Chromatography, Methamphetamine (DJC) (8) Enzyme Immunoassay, Barbiturate (DIS) (8) Enzyme Immunoassay, Methadone (DJR) (8) Enzyme Immunoassay, Phencyclidine (LCM) (6) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (4)

Premarket Exempt

Clear

Identify Health - 01085072100703 Catalog Number : ID-H12-2

Device Description : Identify Health Drug Screen Test CupAMP500/BAR300/BUP10/BZO300/COC150/MDMA500/ME Identify Health Drug Screen Test CupAMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50

Device Class :

Duns Number: 064177324

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

Identify Health Drug Testing Device Test Cups - 01085072100710 Catalog Number : ID-H13-1

Device Description : 13 Panel CLIA Waived Cup - Identify Health AMP500, BAR300, BUP10, BZO300, COC150 13 Panel CLIA Waived Cup - Identify Health AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, OPI300, OXY100, PCP25, TCA1000, THC50 3mm Strip - 25 Pack Box.

Device Class :

Duns Number: 064177324

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

Identify Health Drug Screen Test Cup - 10850013035011 Catalog Number : ID-H7-1

Device Description : Identify Health CLIA Waived 7 Panel Drug Test Cup AMP500/BUP10/BZO300/COC150/OPI Identify Health CLIA Waived 7 Panel Drug Test Cup AMP500/BUP10/BZO300/COC150/OPI300/OXY100/THC50 3.0mm strip/temp strip

Device Class :

Duns Number: 064177324

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

Identify Health - 10850013035028 Catalog Number : ID-H13-1

Device Class :

Duns Number: 064177324

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

Identify Health - 10850013035035 Catalog Number : ID-H12-2

Device Class :

Duns Number: 064177324

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

Identify® Diagnostics Drug Test Cups - 10850013035042 Catalog Number : ID-CP12-BUP-AZ5

Device Description : Identify® Diagnostics Drug Test Cups12-Panel Drug Screening Test CupTHC/COC/MOP/ Identify® Diagnostics Drug Test Cups12-Panel Drug Screening Test CupTHC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY

Device Class :

Duns Number: 064177324

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 5

Identify®Diagnostics Drug Test Cups - 10850013035059 Catalog Number : ID-CP12-BUP-ADULT-AZ5

Device Description : Identify® Diagnostics Drug Test Cups12-Panel Drug Screening Test CupAMP/BAR/BUP/ Identify® Diagnostics Drug Test Cups12-Panel Drug Screening Test CupAMP/BAR/BUP/BZO/COC/MTD/MDMA/MET/MOP/OXY/PCP/THCwith Adulteration strip (S.G./CRE/pH)

Device Class :

Duns Number: 064177324

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 5

Identify®Diagnostics Drug Test Cups - 10850013035066 Catalog Number : ID-CP6-AZ5

Device Description : Identify® Diagnostics Drug Test Cups6-Panel Drug Screening Test CupAMP/BZO/COC/MOP/OXY/THC

Device Class :

Duns Number: 064177324

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 5

Identify®Diagnostics Drug Test Cups - 10850013035073 Catalog Number : ID-CP10-AZ5

Device Description : Identify® Diagnostics Drug Test Cups10-Panel Drug Screening Test CupAMP/BAR/BZO/ Identify® Diagnostics Drug Test Cups10-Panel Drug Screening Test CupAMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC

Device Class :

Duns Number: 064177324

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 5

Identify®Diagnostics Drug Test Cups - 10850013035080 Catalog Number : ID-CP12-BUP-AZ10

Device Class :

Duns Number: 064177324

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 10

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