FDA.reportPublic FDA data

Pantex P674SE

Primary DI
00850039602382
Brand
Pantex P674SE
Company
Pantex
Model
P674SE
Catalog number
674
Device description
Salivary 17ß-Estradiol EIA Stock Calibrator (3,200 pg/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#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850039602389PackageGS11Not in Commercial Distribution
20850039602386PackageGS11In Commercial Distribution
00850039602382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003960238910850039602389
2085003960238620850039602386
00850039602382008500396023828500396023820850039602382

GMDN Terms#

Term, Definition table
TermDefinition
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estradiol (oestradiol) in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
Premarket exempt
true
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
00850039602023Pantex P631SCP631SC6312022-05-23
00850039602030Pantex P631SCP631SC6312022-05-23