FDA.reportPublic FDA data

Pantex Universal

Primary DI
00850039602276
Brand
Pantex Universal
Company
Pantex
Model
1 Universal
Catalog number
635
Device description
Stopping Solution EIA 1 - 15mL
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
CDZRadioimmunoassay, Testosterones And Dihydrotestosterone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDZRadioimmunoassay, Testosterones And DihydrotestosteroneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850039602273PackageGS11Not in Commercial Distribution
20850039602270PackageGS11In Commercial Distribution
00850039602276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003960227310850039602273
2085003960227020850039602270
00850039602276008500396022768500396022760850039602276

GMDN Terms#

Term, Definition table
TermDefinition
Total testosterone 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 testosterone 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
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
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
00850039602047Pantex P631SCP631SC6312022-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336217832Elecsys Testosterone IIRoche Diagnostics GmbHCDZ2026-04-21
05060169690721IDS-iSYS Total TestosteroneIMMUNODIAGNOSTIC SYSTEMS LIMITEDCDZ2026-04-17
05060169691230IDS-iSYS Free TestosteroneIMMUNODIAGNOSTIC SYSTEMS LIMITEDCDZ2025-11-03
04048474015591Testosterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDZ2024-11-22
00894175000763AccuDiag ™Diagnostic Automation, Inc.CDZ2024-01-30
04048474030136Salivary Testosterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDZ2023-09-01
04048474061017Free Testosterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDZ2023-09-01
04048474046380Free Testosterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDZ2023-08-31
00840239030139Salivary Testosterone ELISADRG International IncCDZ2023-08-26
00840239015594Testosterone ELISADRG International IncCDZ2023-08-23
00817830023211MP Biomedicals LLCMp Biomedicals, LLCCDZ2023-08-03
00817830023204MP Biomedicals LLCMp Biomedicals, LLCCDZ2023-08-02
15099590211530ACTIVE Free Testosterone RIAIMMUNOTECH s.r.o.CDZ2023-07-06
00894175000817AccuDiag ™Diagnostic Automation, Inc.CDZ2023-07-05
B652IB59109Testosterone (Free) ELISAIBL AmericaCDZ2023-06-08
00850039602726PantexPantexCDZ2023-03-17
00850039602290PantexPantexCDZ2023-02-17
00850039602672PantexPantexCDZ2023-02-17
04987270235393Lumipulse G Testosterone Immunoreaction CartridgesFUJIREBIO INC.CDZ2023-02-01
04049016137740Free Testosterone ELISAEUROIMMUN Medizinische Labordiagnostika AGCDZ2022-12-08
04049016140085Total Testosterone ELISAEUROIMMUN Medizinische Labordiagnostika AGCDZ2022-12-08
B261CANTE2500DBC Testosterone ELISADiagnostics Biochem Canada IncCDZ2022-11-15
B261CANFTE2600DBC Free Testosterone ELISADiagnostics Biochem Canada IncCDZ2022-11-10
B261CANFTE260LC80DBC Free Testosterone ELISADiagnostics Biochem Canada IncCDZ2022-11-10
00850039602207Pantex P635STPantexCDZ2022-05-23
00850039602214Pantex P635STPantexCDZ2022-05-23
00850039602221Pantex P635STPantexCDZ2022-05-23
00850039602238Pantex P635STPantexCDZ2022-05-23
00850039602245Pantex P635STPantexCDZ2022-05-23
00850039602252Pantex P635STPantexCDZ2022-05-23