Pantex

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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) (1)

Premarket Exempt

No Yes

Clear

Pantex P674SE - 00850039602382 Catalog Number : 674

Device Description : Salivary 17ß-Estradiol EIA Stock Calibrator (3,200 pg/mL)

Device Class :

Duns Number: 072296809

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Pantex P674SE - 00850039602399 Catalog Number : 674

Device Description : Salivary 17ß-Estradiol EIA Control 1

Device Class :

Duns Number: 072296809

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Pantex P674SE - 00850039602405 Catalog Number : 674

Device Description : Salivary 17ß-Estradiol EIA Control 2

Device Class :

Duns Number: 072296809

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Pantex P674SE - 00850039602412 Catalog Number : 674

Device Description : Salivary 17ß-Estradiol EIA HRP Enzyme Conjugate (Concentrated 20x)

Device Class :

Duns Number: 072296809

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Pantex P674SE - 00850039602429 Catalog Number : 674

Device Description : Salivary 17ß-Estradiol EIA Antibody

Device Class :

Duns Number: 072296809

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Pantex P674SE - 00850039602436 Catalog Number : 674

Device Description : Salivary 17ß-Estradiol EIA Conjugate Buffer

Device Class :

Duns Number: 072296809

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Pantex P674SE - 00850039602443 Catalog Number : 674

Device Description : Salivary 17ß-Estradiol EIA Assay Diluent

Device Class :

Duns Number: 072296809

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Pantex Universal - 00850039602689 Catalog Number : 16465-260

Device Description : Pantex Sample Collection Device single

Device Class : 2

Duns Number: 072296809

Premarket Exempt : No

Product Code : NHG

Prescription Use : Yes

Device Count : 1

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