FDA.reportPublic FDA data

ACTIVE Free Testosterone RIA

Primary DI
15099590211530
Brand
ACTIVE Free Testosterone RIA
Company
IMMUNOTECH s.r.o.
Model
DSL4900
Catalog number
DSL4900
Device description
ACTIVE Free Testosterone RIA
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CDZRadioimmunoassay, Testosterones And Dihydrotestosterone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191350000ACTIVE® Free Testosterone RIAImmunotech S.R.O.2019-12-20CDZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590211530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959021153015099590211530

GMDN Terms#

Term, Definition table
TermDefinition
Free testosterone IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free testosterone in a clinical specimen, using a radioimmunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
360561849
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590211509DHEA-S-7 RIADSL2700DSL27002023-07-06
15099590211523Ultra-sensitive Estradiol RIADSL4800DSL48002023-07-06
15099590211547Estrone-sulfate RIADSL5400DSL54002023-07-06
15099590211615Estrone RIADSL8700DSL87002023-07-06
15099590211622DHEA RIADSL8900DSL89002023-07-06
15099590211592ACTIVE Aldosterone RIADSL8600DSL86002016-09-09

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
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
00850039602269Pantex UniversalPantexCDZ2022-05-23