MEDTOX DIAGNOSTICS, INC.

Address:1238 Anthony Rd,BURLINGTON,NC,27215,US

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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

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (JQC) (3) Semen Analysis Device (POV) (3)

Premarket Exempt

No Yes

Clear

Men's Rapid Fertility Test - 00862105000305 Catalog Number :

Device Description : Men's Rapid Fertility Test, 2-Test Kit

Device Class : 2

Duns Number: 118569262

Premarket Exempt : No

Product Code : POV

Prescription Use : No

Device Count : 1

Men's Rapid Fertility Test - 00862105000312 Catalog Number :

Device Description : Men's Rapid Fertility Test, 2-Test Refill Kit

Device Class : 2

Duns Number: 118569262

Premarket Exempt : No

Product Code : POV

Prescription Use : No

Device Count : 1

Torq - 00862105000336 Catalog Number :

Device Description : Torq ZDrive MR, BD Microtainer

Device Class : 1

Duns Number: 118569262

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : No

Device Count : 1

Torq - 00862105000343 Catalog Number :

Device Description : Torq MiniDrive2

Device Class : 1

Duns Number: 118569262

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : No

Device Count : 1

Torq - 00862105000374 Catalog Number :

Device Description : Torq ZDrive MR, Ram Scientific

Device Class : 1

Duns Number: 118569262

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : No

Device Count : 1

Trak - 00862105000398 Catalog Number :

Device Description : Trak Male Fertility Testing System, 1-Test Kit

Device Class : 2

Duns Number: 118569262

Premarket Exempt : No

Product Code : POV

Prescription Use : No

Device Count : 1

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