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

Radioimmunoassay, Testosterones And Dihydrotestosterone (CDZ) (4)

Premarket Exempt

No Yes

Clear

Pantex P635ST - 00850039602245 Catalog Number : 635

Device Description : Salivary Testosterone EIA Conjugate Buffer

Device Class : 1

Duns Number: 072296809

Premarket Exempt : No

Product Code : CDZ

Prescription Use : Yes

Device Count : 1

Pantex P635ST - 00850039602252 Catalog Number : 635

Device Description : Salivary Testosterone EIA Assay Diluent

Device Class : 1

Duns Number: 072296809

Premarket Exempt : No

Product Code : CDZ

Prescription Use : Yes

Device Count : 1

Pantex Universal - 00850039602269 Catalog Number : 635

Device Description : Color Development Reagent EIA 1 - 15mL

Device Class : 1

Duns Number: 072296809

Premarket Exempt : No

Product Code : CDZ

Prescription Use : Yes

Device Count : 1

Pantex Universal - 00850039602276 Catalog Number : 635

Device Description : Stopping Solution EIA 1 - 15mL

Device Class : 1

Duns Number: 072296809

Premarket Exempt : No

Product Code : CDZ

Prescription Use : Yes

Device Count : 1

Pantex P637SP - 00850039602306 Catalog Number : 637

Device Description : Salivary Progesterone EIA Stock Calibrator (100,000 pg/mL)

Device Class :

Duns Number: 072296809

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Pantex P637SP - 00850039602313 Catalog Number : 637

Device Description : Salivary Progesterone EIA Stock Control (50,000 pg/mL)

Device Class :

Duns Number: 072296809

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Pantex P637SP - 00850039602320 Catalog Number : 637

Device Description : Salivary Progesterone EIA HRP Enzyme (Concentrated 40x)

Device Class :

Duns Number: 072296809

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Pantex P637SP - 00850039602337 Catalog Number : 637

Device Description : Salivary Progesterone EIA Antibody

Device Class :

Duns Number: 072296809

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Pantex P637SP - 00850039602344 Catalog Number : 637

Device Description : Salivary Progesterone EIA Conjugate Buffer

Device Class :

Duns Number: 072296809

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Pantex P637SP - 00850039602351 Catalog Number : 637

Device Description : Salivary Progesterone EIA Assay Diluent

Device Class :

Duns Number: 072296809

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

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