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 - 00840937100103 Catalog Number :

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

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100110 Catalog Number :

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

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100127 Catalog Number :

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

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100134 Catalog Number :

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

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100141 Catalog Number :

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

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100158 Catalog Number :

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

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100165 Catalog Number :

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

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100172 Catalog Number :

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

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100189 Catalog Number :

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

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100196 Catalog Number :

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

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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