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 - 00840937100301 Catalog Number :

Device Description : Immunalysis Corporation LSD Direct ELISA Kit: 2 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100318 Catalog Number :

Device Description : Immunalysis Corporation Flunitrazepam Direct ELISA Kit: 1 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100325 Catalog Number :

Device Description : Immunalysis Corporation Cotinine Direct ELISA Kit (Nicotine Metabolite): 1 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100332 Catalog Number :

Device Description : Immunalysis Corporation Cotinine Direct ELISA Kit (Nicotine Metabolite): 5 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100349 Catalog Number :

Device Description : Immunalysis Corporation Fentanyl Direct ELISA Kit: 1 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100356 Catalog Number :

Device Description : Immunalysis Corporation Fentanyl Direct ELISA Kit: 5 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100363 Catalog Number :

Device Description : Immunalysis Corporation Fentanyl Direct ELISA Kit: 50 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100400 Catalog Number :

Device Description : Immunalysis Corporation Meperidine (Demerol/Pethidine) Direct ELISA Kit: 1 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100417 Catalog Number :

Device Description : Immunalysis Corporation Meperidine (Demerol/Pethidine) Direct ELISA Kit: 5 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100424 Catalog Number :

Device Description : Immunalysis Corporation Meperidine (Demerol/Pethidine) Direct ELISA Kit: 50 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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