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

Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (LHL) (4) Elisa, Antibody, West Nile Virus (NOP) (3) Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific (LGC) (3)

Premarket Exempt

No Yes

Clear

Legionella IFA Polyvalent Conjugate - 10816101020017 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : Yes

Product Code : LHL

Prescription Use : No

Device Count : 1

Legionella IFA Non-Detectable Control - 10816101020024 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : Yes

Product Code : LHL

Prescription Use : No

Device Count : 1

Legionella IFA Detectable Control - 10816101020031 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : Yes

Product Code : LHL

Prescription Use : No

Device Count : 1

Legionella IFA Substrate Slides - 10816101020055 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : Yes

Product Code : LHL

Prescription Use : No

Device Count : 1

HSV-1 AND HSV-2 Differentiation Immunoblot IgG Antigen Strips - 10816101021014 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : No

Product Code : LGC

Prescription Use : No

Device Count : 1

HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive Control - 10816101021021 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : No

Product Code : LGC

Prescription Use : No

Device Count : 1

HSV-1 and HSV-2 Immunoblot IgG Negative Control - 10816101021038 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : No

Product Code : LGC

Prescription Use : No

Device Count : 1

West Nile Virus DxSelect™ Negative Control - 10816101022042 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : No

Product Code : NOP

Prescription Use : No

Device Count : 1

West Nile Virus IgM Capture DxSelect™ Positive Control - 10816101022059 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : No

Product Code : NOP

Prescription Use : No

Device Count : 1

West Nile Virus IgM Capture DxSelect™ Antigen - 10816101022066 Catalog Number :

Device Class : 2

Duns Number: 080271715

Premarket Exempt : No

Product Code : NOP

Prescription Use : No

Device Count : 1

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