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

No Yes

Clear

Immunalysis Corporation - 00840937111420 Catalog Number :

Device Description : Immunalysis Corporation EDDP Specific Urine Calibrator Level 4 - 1000 ng/mL

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111437 Catalog Number :

Device Description : Immunalysis Corporation EDDP Specific Urine Control Set Level 1

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111444 Catalog Number :

Device Description : Immunalysis Corporation EDDP Specific Urine Control Set Level 2

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111451 Catalog Number :

Device Description : Immunalysis Corporation EDDP Specific Urine HEIA 25 Kit

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111468 Catalog Number :

Device Description : Immunalysis Corporation Fentanyl Urine Calibrator Level 1 - 1 ng/mL

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111475 Catalog Number :

Device Description : Immunalysis Corporation Fentanyl Urine Control Set

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111482 Catalog Number :

Device Description : Immunalysis Corporation SEFRIA Fentanyl Urine Kit 25

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111499 Catalog Number :

Device Description : Immunalysis Corporation Negative Calibrator

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111505 Catalog Number :

Device Description : Immunalysis Corporation Oxycodone Urine Calibrator 100

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937111512 Catalog Number :

Device Description : Immunalysis Corporation Oxycodone Urine Calibrator 300

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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