DIASORIN MOLECULAR LLC

Address:11331 Valley View St,CYPRESS,CA,90630,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

Real Time Nucleic Acid Amplification System (OOI) (5) Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System (PLO) (2) Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples (PGI) (1)

Premarket Exempt

Yes No

Clear

Simplexa™ VZV Swab Direct - 20816101025712 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : No

Product Code : PGI

Prescription Use : Yes

Device Count : 1

Simplexa™ VZV Direct - 20816101025774 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : No

Product Code : PLO

Prescription Use : Yes

Device Count : 1

Simplexa™ VZV Positive Control Pack - 20816101025781 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : No

Product Code : PLO

Prescription Use : Yes

Device Count : 1

Simplexa™ Flu A/B & RSV Direct Gen II - 20816101026962 Catalog Number :

Device Class :

Duns Number: 080271715

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Universal Disc - 30816101025078 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Direct Amplification Disc - 30816101025085 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Direct Amplification Disc Kit - 30816101025092 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : No

Product Code : OOI

Prescription Use : Yes

Device Count : 1

Universal Disc - 40816101025075 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Direct Amplification Disc - 40816101025082 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

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