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

Salivary Estriol Test (PEJ) (2) Enzyme Immunoassasy, Nocotine And Nicotine Metabolites (MKU) (1) Radioimmunoassay, Progesterone (JLS) (1) Test System, Nicotine, Cotinine, Metabolites (MRS) (1)

Premarket Exempt

No Yes

Clear

Salimetrics - 00859410006108 Catalog Number : 1-2112

Device Description : High Sensitivity Salivary Cotinine Quantitative Enzyme Immunoassay Kit

Device Class : 1

Duns Number: 084843064

Premarket Exempt : Yes

Product Code : MKU, MRS

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006115 Catalog Number : 1-2502-25

Device Description : Salivary Progesterone Enzyme Immunoassay Kit (25-pack)

Device Class : 1

Duns Number: 084843064

Premarket Exempt : Yes

Product Code : JLS

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006122 Catalog Number : 1-2212-5

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

Device Class :

Duns Number: 084843064

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006139 Catalog Number : 1-2312

Device Description : Expanded Range Salivary Testosterone Enzyme Immunoassay Kit

Device Class :

Duns Number: 084843064

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006146 Catalog Number : 1-2212

Device Description : Salivary DHEA Enzyme Immunoassay Kit

Device Class :

Duns Number: 084843064

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006153 Catalog Number : 1-2812

Device Description : High Sensitivity Salivary Estriol Enzyme Immunoassay Kit

Device Class : 3

Duns Number: 084843064

Premarket Exempt : Yes

Product Code : PEJ

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006160 Catalog Number : 1-2812-5

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

Device Class : 3

Duns Number: 084843064

Premarket Exempt : Yes

Product Code : PEJ

Prescription Use : No

Device Count : 1

Salimetrics - 00859410006177 Catalog Number : 1-2312-5

Device Description : Expanded Range Salivary Testosterone Enzyme Immunoassay Kit (5-pack)

Device Class :

Duns Number: 084843064

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

SalivaBio - 00859410006184 Catalog Number : 5001.08

Device Description : SalivaBio Infant Swab (SIS) PK/50

Device Class :

Duns Number: 084843064

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

SalivaBio - 00859410006191 Catalog Number : 5001.02

Device Description : SalivaBio Oral Swab (SOS) PK/50

Device Class :

Duns Number: 084843064

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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