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 - 00840937100202 Catalog Number :

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

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100219 Catalog Number :

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

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100226 Catalog Number :

Device Description : Immunalysis Corporation Cocaine/Benzoylecgonine Direct ELISA Kit: 2 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100233 Catalog Number :

Device Description : Immunalysis Corporation Cocaine/Benzoylecgonine Direct ELISA Kit: 5 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100240 Catalog Number :

Device Description : Immunalysis Corporation Cocaine/Benzoylecgonine Direct ELISA Kit: 50 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100257 Catalog Number :

Device Description : Immunalysis Corporation Morphine Specific Direct ELISA Kit: 2 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100264 Catalog Number :

Device Description : Immunalysis Corporation Morphine Specific Direct ELISA Kit: 5 plate

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100271 Catalog Number :

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

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100288 Catalog Number :

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

Device Class :

Duns Number: 080589004

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Immunalysis Corporation - 00840937100295 Catalog Number :

Device Description : Immunalysis Corporation Benzodiazepines 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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