IMMUNALYSIS CORPORATION

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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

Premarket Exempt

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Immunalysis Corporation - 00840937111529 Catalog Number :

Device Description : Immunalysis Corporation Oxycodone Urine Calibrator Set

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111536 Catalog Number :

Device Description : Immunalysis Corporation Oxycodone Urine Control Set 100

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111543 Catalog Number :

Device Description : Immunalysis Corporation Oxycodone Urine Control Set 300

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111550 Catalog Number :

Device Description : Immunalysis Corporation Oxycodone Urine HEIA 25

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111567 Catalog Number :

Device Description : Immunalysis Corporation Tramadol Urine Calibrator

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111574 Catalog Number :

Device Description : Immunalysis Corporation Tramadol Urine Calibrator Set

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111581 Catalog Number :

Device Description : Immunalysis Corporation Tramadol Urine Control Set

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111598 Catalog Number :

Device Description : Immunalysis Corporation Tramadol Urine HEIA Kit 25

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111604 Catalog Number :

Device Description : Immunalysis Corporation Negative Reference Calibrator

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111611 Catalog Number : 314-0025EX

Device Description : Immunalysis Corporation Benzodiazepines Oral Fluid Export Kit 25

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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