Pantex

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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) (9)

Premarket Exempt

No Yes

Clear

Pantex P631SC - 00850039602009 Catalog Number : 631

Device Description : Gargg Plate - 96 Wells

Device Class :

Duns Number: 072296809

Premarket Exempt : No

Product Code : NHG

Prescription Use : Yes

Device Count : 1

Pantex P631SC - 00850039602016 Catalog Number : 631

Device Description : Salivary Cortisol EIA Calibrator 0 ng/mL

Device Class :

Duns Number: 072296809

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Pantex P631SC - 00850039602023 Catalog Number : 631

Device Description : Salivary Cortisol EIA Calibrator 0.1 ng/mL

Device Class : 2

Duns Number: 072296809

Premarket Exempt : No

Product Code : NHG

Prescription Use : Yes

Device Count : 1

Pantex P631SC - 00850039602030 Catalog Number : 631

Device Description : Salivary Cortisol EIA Calibrator 0.3 ng/mL

Device Class : 2

Duns Number: 072296809

Premarket Exempt : No

Product Code : NHG

Prescription Use : Yes

Device Count : 1

Pantex P631SC - 00850039602047 Catalog Number : 631

Device Description : Salivary Cortisol EIA Calibrator 1.0 ng/mL

Device Class : 2

Duns Number: 072296809

Premarket Exempt : No

Product Code : NHG

Prescription Use : Yes

Device Count : 1

Pantex P631SC - 00850039602054 Catalog Number : 631

Device Description : Salivary Cortisol EIA Calibrator 3.0 ng/mL

Device Class : 2

Duns Number: 072296809

Premarket Exempt : No

Product Code : NHG

Prescription Use : Yes

Device Count : 1

Pantex P631SC - 00850039602061 Catalog Number : 631

Device Description : Salivary Cortisol EIA Calibrator 10 ng/mL

Device Class : 2

Duns Number: 072296809

Premarket Exempt : No

Product Code : NHG

Prescription Use : Yes

Device Count : 1

Pantex P631SC - 00850039602078 Catalog Number : 631

Device Description : Salivary Cortisol EIA Calibrator 30 ng/mL

Device Class : 2

Duns Number: 072296809

Premarket Exempt : No

Product Code : NHG

Prescription Use : Yes

Device Count : 1

Pantex P631SC - 00850039602085 Catalog Number : 631

Device Description : Salivary Cortisol EIA Control Level 1

Device Class : 2

Duns Number: 072296809

Premarket Exempt : No

Product Code : NHG

Prescription Use : Yes

Device Count : 1

Pantex P631SC - 00850039602092 Catalog Number : 631

Device Description : Salivary Cortisol EIA Control Level 2

Device Class : 2

Duns Number: 072296809

Premarket Exempt : No

Product Code : NHG

Prescription Use : Yes

Device Count : 1

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