AGGREDYNE, INC.

Address:10530 Rockley Rd Ste 150,Houston,TX,77099,US

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Filters

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

System, Automated Platelet Aggregation (JOZ) (3)

Premarket Exempt

Clear

AggreDYNE AA Assay - 00856893004010 Catalog Number :

Device Description : AA Assay Cartridge, Single Use Packaged

Device Class :

Duns Number: 078703793

Premarket Exempt : No

Product Code : JOZ

Prescription Use : Yes

Device Count : 1

Aggreguide - 00856893004027 Catalog Number : 12020

Device Description : AggreDYNE A-100 ADP Assay

Device Class :

Duns Number: 078703793

Premarket Exempt : No

Product Code : JOZ

Prescription Use : Yes

Device Count : 1

Aggreguide - 00856893004065 Catalog Number :

Device Description : Whole Blood Aggregometer

Device Class :

Duns Number: 078703793

Premarket Exempt : No

Product Code : JOZ

Prescription Use : Yes

Device Count : 1

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