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

Test, Opiates, Employment And Insurance Testing, Exempt (PVH) (2) Calibrators, Drug Mixture (DKB) (1)

Premarket Exempt

No Yes

Clear

Immunalysis Corporation - 00840937111772 Catalog Number : 10039-15

Device Description : Immunalysis Corporation - Tapentadol Urine Calibrator - 100 ng/mL

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937111789 Catalog Number : 10040-15

Device Description : Immunalysis Corporation - Tapentadol Urine Calibrator - 200 ng/mL

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937111796 Catalog Number : 10041-15

Device Description : Immunalysis Corporation - Tapentadol Urine Calibrator - 300 ng/mL

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937111802 Catalog Number : 10042-15

Device Description : Immunalysis Corporation - Tapentadol Urine Calibrator - 1000 ng/mL

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937111819 Catalog Number : 3014-15

Device Description : Immunalysis Corporation - Tapentadol Urine Control Set

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Immunalysis Corporation - 00840937111826 Catalog Number : QSI-0025

Device Description : Immunalysis Corporation - Quantisal Saliva Collection Devices - 25 Per Box

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111833 Catalog Number : QSI-0500

Device Description : Immunalysis Corporation - Quantisal Saliva Collection Devices - 500 Per Box

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111840 Catalog Number : 607OF-0100

Device Description : Immunalysis SEFRIA Opiates Oral Fluid Enzyme Immunoassay -100 mL Kit

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : PVH

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111857 Catalog Number : 607OF-0500

Device Description : Immunalysis SEFRIA Opiates Oral Fluid Enzyme Immunoassay - 500 mL Kit

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : PVH

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111895 Catalog Number : 10055-10

Device Description : Immunalysis Multi-Drug OF Calibrator Level 1

Device Class : 2

Duns Number: 080589004

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

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