FDA.reportPublic FDA data

Pantex P631SC

Primary DI
00850039602023
Brand
Pantex P631SC
Company
Pantex
Model
P631SC
Catalog number
631
Device description
Salivary Cortisol EIA Calibrator 0.1 ng/mL
Published
2022-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHGEnzyme Immunoassay, Cortisol, Salivary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHGEnzyme Immunoassay, Cortisol, SalivaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850039602020PackageGS11Not in Commercial Distribution
20850039602027PackageGS11In Commercial Distribution
00850039602023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003960202010850039602020
2085003960202720850039602027
00850039602023008500396020238500396020230850039602023

GMDN Terms#

Term, Definition table
TermDefinition
Total cortisol IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cortisol in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis and treatment of adrenal disorders.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-310-828-7423info@pantexba.com

Regulatory Flags#

DUNS number
072296809
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850039602207Pantex P635STP635ST6352022-05-23
00850039602214Pantex P635STP635ST6352022-05-23
00850039602221Pantex P635STP635ST6352022-05-23
00850039602238Pantex P635STP635ST6352022-05-23
00850039602245Pantex P635STP635ST6352022-05-23
00850039602252Pantex P635STP635ST6352022-05-23
00850039602269Pantex Universal1 Universal6352022-05-23
00850039602276Pantex Universal1 Universal6352022-05-23
00850039602726PantexN/A6352023-03-17
00850039602290PantexN/A6352023-02-17
00850039602672PantexN/A6352023-02-17
00850039602191PantexN/A6312023-02-17
00850039602375PantexN/A6372023-02-17
00850039602467PantexN/A6742023-02-17
00850039602719PantexN/A6312023-03-17
00850039602733PantexN/A6372023-03-17
00850039602740PantexN/A6742023-03-17
00850039602016Pantex P631SCP631SC6312022-05-23
00850039602030Pantex P631SCP631SC6312022-05-23
00850039602047Pantex P631SCP631SC6312022-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850039602719PantexPantexNHG2023-03-17
00850039602191PantexPantexNHG2023-02-17
00850039602030Pantex P631SCPantexNHG2022-05-23
00850039602047Pantex P631SCPantexNHG2022-05-23
00850039602054Pantex P631SCPantexNHG2022-05-23
00850039602061Pantex P631SCPantexNHG2022-05-23
00850039602078Pantex P631SCPantexNHG2022-05-23
00850039602085Pantex P631SCPantexNHG2022-05-23
00850039602092Pantex P631SCPantexNHG2022-05-23
00850039602108Pantex P631SCPantexNHG2022-05-23
00850039602115Pantex P631SCPantexNHG2022-05-23
00850039602122Pantex P631SCPantexNHG2022-05-23
00850039602139Pantex P631SCPantexNHG2022-05-23
00850039602146Pantex P631SCPantexNHG2022-05-23
00850039602153Pantex UniversalPantexNHG2022-05-23
00850039602009Pantex P631SCPantexNHG2022-05-23
10850039602020Pantex P631SCPantexNHG2022-05-23
10850039602037Pantex P631SCPantexNHG2022-05-23
10850039602044Pantex P631SCPantexNHG2022-05-23
10850039602051Pantex P631SCPantexNHG2022-05-23
10850039602068Pantex P631SCPantexNHG2022-05-23
10850039602075Pantex P631SCPantexNHG2022-05-23
10850039602082Pantex P631SCPantexNHG2022-05-23
10850039602099Pantex P631SCPantexNHG2022-05-23
10850039602105Pantex P631SCPantexNHG2022-05-23
10850039602112Pantex P631SCPantexNHG2022-05-23
10850039602129Pantex P631SCPantexNHG2022-05-23
10850039602136Pantex P631SCPantexNHG2022-05-23
10850039602143Pantex P631SCPantexNHG2022-05-23
10850039602150Pantex UniversalPantexNHG2022-05-23