W.H.P.M. INC.

Address:5358 Irwindale Ave,Irwindale,CA,91706,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

Reagent, Occult Blood (KHE) (7) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (2) Enzyme Immunoassay, Cannabinoids (LDJ) (2) Enzyme Immunoassay, Barbiturate (DIS) (1) Enzyme Immunoassay, Amphetamine (DKZ) (1) Enzyme Immunoassay, Opiates (DJG) (1) Enzyme Immunoassay, Phencyclidine (LCM) (1) Gas Chromatography, Methamphetamine (LAF) (1) Enzyme Immunoassay, Benzodiazepine (JXM) (1)

Premarket Exempt

No Yes

Clear

ADS Medical - 00811925030009 Catalog Number :

Device Description : ADS Medical iFOB Test Kit, 30 Cassettes and 50 Collection Tubes per Box Kit with ADS Medical iFOB Test Kit, 30 Cassettes and 50 Collection Tubes per Box Kit with 50 Mailers

Device Class :

Duns Number: 602085672

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 30

ADS Medical - 00811925030023 Catalog Number :

Device Description : ADS Medical iFOB Test Kit, 30 Cassettes and 30 Collection Tubes per Box Kit without Mailer

Device Class :

Duns Number: 602085672

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 30

ADS Medical - 00811925030030 Catalog Number :

Device Description : ADS Medical iFOB Test Kit, 50 Cassettes and 50 Collection Tubes per Box Kit without Mailer

Device Class :

Duns Number: 602085672

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 50

ADS Medical - 00811925030047 Catalog Number :

Device Description : ADS Medical iFOB Test, 30 Cassettes per Box

Device Class :

Duns Number: 602085672

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 30

ADS Medical - 00811925030054 Catalog Number :

Device Description : ADS Medical iFOB Test, 50 Cassettes per Box

Device Class :

Duns Number: 602085672

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 50

ADS Medical - 00811925030061 Catalog Number :

Device Description : ADS Medical iFOB Collection Tube, 30 Purple Cap Collection Tubes with Short Label per Box

Device Class :

Duns Number: 602085672

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 30

ADS Medical - 00811925030078 Catalog Number :

Device Description : ADS Medical iFOB Collection Tube, 50 Purple Cap Collection Tubes with Short Label per Box

Device Class :

Duns Number: 602085672

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 50

First Sign® - 00817763022565 Catalog Number : FSCCUPCO-25P

Device Description : DOA Single Test Cup, 25Pcs/Box, CLIA Waived; First Sign for Hemosure, CLIA Waived, COC

Device Class : 2

Duns Number: 602085672

Premarket Exempt : Yes

Product Code : DIO

Prescription Use : Yes

Device Count : 25

CRL Stat Dip Card - 00817815020471 Catalog Number : KCUR920121P

Device Description : DOA 8 in 1 Test CRL Stat Dip Card W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 MET1000 DOA 8 in 1 Test CRL Stat Dip Card W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 MET1000 BAR300 BZO300 COC300 THC50 PCP25 OPI2000 & CR, NI, OX, PH, SG

Device Class :

Duns Number: 602085672

Premarket Exempt : Yes

Product Code : LCM, LDJ, DJG, JXM, LAF, DIS, DIO, DKZ

Prescription Use : Yes

Device Count : 25

NA - 00841824100602 Catalog Number :

Device Description : DOA Single Test Dipcard, 25Pcs/Box Clia WaivedTHC

Device Class :

Duns Number: 602085672

Premarket Exempt : No

Product Code : LDJ

Prescription Use : Yes

Device Count : 25

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