FDA.reportPublic FDA data

Pantex P674SE

Primary DI
10850039602419
Brand
Pantex P674SE
Company
Pantex
Model
P674SE
Catalog number
674
Device description
Salivary 17ß-Estradiol EIA HRP Enzyme Conjugate (Concentrated 20x)
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#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850039602419PackageGS11In Commercial Distribution
20850039602416PackageGS11In Commercial Distribution
00850039602412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003960241910850039602419
2085003960241620850039602416
00850039602412008500396024128500396024120850039602412

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

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
true
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