FDA.reportPublic FDA data

Alinity

Primary DI
00380740151393
Brand
Alinity
Company
Abbott GmbH
Model
09P3820
Catalog number
09P3820
Device description
Alinity i SHBG Reagent Kit
Published
2018-07-12
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
00380740151393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740151393003807401513933807401513930380740151393

GMDN Terms#

Term, Definition table
TermDefinition
Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of sex hormone binding globulin (SHBG) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
315786293
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
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

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Primary DI, Brand, Company table
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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