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) (6) Drug Mixture Control Materials (DIF) (2) Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device (PJD) (2)

Premarket Exempt

No Yes

Clear

Immunalysis Corporation - 00840937111918 Catalog Number : 10056-10

Device Description : Immunalysis Multi-Drug OF Calibrator Level 2

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937111925 Catalog Number : 10057-10

Device Description : Immunalysis Multi-Drug OF Calibrator Level 3

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937111932 Catalog Number : 10058-10

Device Description : Immunalysis Multi-Drug OF Calibrator Level 4

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937111949 Catalog Number : 3016-10

Device Description : Immunalysis Multi-Drug OF Control Set - Low and High Control

Device Class : 1

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937111956 Catalog Number : NegOFC-0100

Device Description : Immunalysis Synthetic Negative Oral Fluid 100 mL

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937111963 Catalog Number : NegOFC-0500

Device Description : Immunalysis Synthetic Negative Oral Fluid 500 mL

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Quantisal - 00840937112052 Catalog Number : QSI-POUCH

Device Description : Quantisal I (25/100) Test

Device Class : 2

Duns Number: 080589004

Premarket Exempt : No

Product Code : PJD

Prescription Use : Yes

Device Count : 1

Quantisal - 00840937112069 Catalog Number : QSII-BOX

Device Description : Quantisal II Product Box

Device Class : 2

Duns Number: 080589004

Premarket Exempt : No

Product Code : PJD

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937112076 Catalog Number : 3017-10

Device Description : AMP/6-AM Oral Fluid Control Set

Device Class : 1

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937112083 Catalog Number : 10054-10

Device Description : AMP/6-AM Oral Fluid Calibrator Level 4

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

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