IMMUNALYSIS CORPORATION

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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

Calibrators, Drug Mixture (DKB) (3) Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device (PJD) (3) Test, Cannabinoid, Employment And Insurance Testing, Exempt (PVJ) (2) Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt (PVA) (2)

Premarket Exempt

No Yes

Clear

Immunalysis Corporation - 00840937112090 Catalog Number : 10053-10

Device Description : AMP/6-AM Oral Fluid Calibrator Level 3

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937112106 Catalog Number : 10052-10

Device Description : AMP/6-AM Oral Fluid Calibrator Level 2

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937112113 Catalog Number : 10051-10

Device Description : AMP/6-AM Oral Fluid Calibrator Level 1

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

SEFRIA™ - 00840937112120 Catalog Number :

Device Description : SEFRIA™ Cocaine/Benzoylecgonine Oral Fluid Kit 100

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : PVA

Prescription Use : No

Device Count : 1

SEFRIA™ - 00840937112137 Catalog Number :

Device Description : SEFRIA™ Cocaine/Benzoylecgonine Oral Fluid Kit 500

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : PVA

Prescription Use : No

Device Count : 1

Quantisal - 00840937112144 Catalog Number : QSII-0025

Device Description : Quantisal II Oral Fluid Collection Device 25pk

Device Class : 2

Duns Number: 080589004

Premarket Exempt : No

Product Code : PJD

Prescription Use : Yes

Device Count : 1

Quantisal - 00840937112151 Catalog Number : QSI-0025

Device Description : Quantisal Oral Fluid Collection Device 25 pk

Device Class : 2

Duns Number: 080589004

Premarket Exempt : No

Product Code : PJD

Prescription Use : Yes

Device Count : 1

Quantisal - 00840937112168 Catalog Number : QSI-0500

Device Description : Quantisal Oral Fluid Collection Device 500pk

Device Class : 2

Duns Number: 080589004

Premarket Exempt : No

Product Code : PJD

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937112175 Catalog Number : 324OF-0100

Device Description : Cannabinoid Oral Fluid HEIA 100 mL

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : PVJ

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937112182 Catalog Number : 324OF-0500

Device Description : Cannabinoid Oral Fluid HEIA 500 mL

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : PVJ

Prescription Use : Yes

Device Count : 1

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