SALIMETRICS, LLC

Address:101 INNOVATION BLVD STE 302,State College,PA,16803,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

Enzyme Immunoassay, Cortisol, Salivary (NHG) (3) Radioimmunoassay, Estradiol (CHP) (3) Radioimmunoassay, Progesterone (JLS) (2) Enzyme Immunoassasy, Nocotine And Nicotine Metabolites (MKU) (1) Test System, Nicotine, Cotinine, Metabolites (MRS) (1)

Premarket Exempt

No Yes

Clear

SalivaBio - 00859410006009 Catalog Number : 5016.04

Device Description : SalivaBio Saliva Collection Aid PK/50

Device Class :

Duns Number: 084843064

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006016 Catalog Number : 1-3102-5

Device Description : Expanded Range High Sensitivity Salivary Cortisol Enzyme Immunoassay Kit (5-pack)

Device Class : 2

Duns Number: 084843064

Premarket Exempt : No

Product Code : NHG

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006023 Catalog Number : 1-3102-25

Device Description : Expanded Range High Sensitivity Salivary Cortisol Enzyme Immunoassay Kit (25 pack)

Device Class : 2

Duns Number: 084843064

Premarket Exempt : No

Product Code : NHG

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006030 Catalog Number : 1-3102

Device Description : Expanded Range High Sensitivity Salivary Cortisol Enzyme Immunoassay Kit

Device Class : 2

Duns Number: 084843064

Premarket Exempt : No

Product Code : NHG

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006047 Catalog Number : 1-2502

Device Description : Salivary Progesterone Enzyme Immunoassay Kit

Device Class : 1

Duns Number: 084843064

Premarket Exempt : Yes

Product Code : JLS

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006054 Catalog Number : 1-2502-5

Device Description : Salivary Progesterone Enzyme Immunoassay Kit (5-pack)

Device Class : 1

Duns Number: 084843064

Premarket Exempt : Yes

Product Code : JLS

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006061 Catalog Number : 1-4702-25

Device Description : High Sensitivity Salivary 17Beta-Estradiol Enzyme Immunoassay Kit (25-pack)

Device Class : 1

Duns Number: 084843064

Premarket Exempt : Yes

Product Code : CHP

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006078 Catalog Number : 1-4702-5

Device Description : High Sensitivity Salivary 17Beta-Estradiol Enzyme Immunoassay Kit (5-pack)

Device Class : 1

Duns Number: 084843064

Premarket Exempt : Yes

Product Code : CHP

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006085 Catalog Number : 1-4702

Device Description : High Sensitivity Salivary 17Beta-Estradiol Enzyme Immunoassay Kit

Device Class : 1

Duns Number: 084843064

Premarket Exempt : Yes

Product Code : CHP

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006092 Catalog Number : 1-2112-5

Device Description : High Sensitivity Salivary Cotinine Quantitative Enzyme Immunoassay Kit (5-pack)

Device Class : 1

Duns Number: 084843064

Premarket Exempt : Yes

Product Code : MRS, MKU

Prescription Use : No

Device Count : 1

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