FDA.reportPublic FDA data

Pantex P631SC

Primary DI
10850039602020
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10850039602020PackageGS11In 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
072296809
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850039602023Pantex P631SCP631SC6312022-05-23
00850039602030Pantex P631SCP631SC6312022-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850039602719PantexPantexNHG2023-03-17
00850039602191PantexPantexNHG2023-02-17
00850039602023Pantex P631SCPantexNHG2022-05-23
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
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