FDA.reportPublic FDA data

Alinity

Primary DI
00380740174910
Brand
Alinity
Company
Abbott Ireland Diagnostics
Model
04V3730
Catalog number
04V3730
Device description
Alinity i STAT Myoglobin Reagent Kit 1000 Tests
Published
2019-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DDRMYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DDRMyoglobin, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740174910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740174910003807401749103807401749100380740174910

GMDN Terms#

Term, Definition table
TermDefinition
Myoglobin IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of myoglobin in a clinical specimen, using a chemiluminescent immunoassay 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(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
985307301
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
00380740153953Alinity01R182101R18212019-01-04
00380740168742Alinity04W020104W02012025-12-11
00380740168759Alinity04W021004W02102025-12-11
00380740168780Alinity04W022204W02222025-12-11
00380740197742Alinity04W212704W21272025-10-14
00380740213893Alinity04W210204W21022025-10-14
00380740213909Alinity04W211204W21122025-10-14
00380740136772Alinity06P020406P02042019-09-14
00380740136789Alinity06P035906P03592019-09-14
00380740136796Alinity06P021306P02132019-09-14
00380740136802Alinity06P021506P02152019-09-14
00380740136819Alinity06P026006P02602019-09-14
00380740150990Alinity09P412009P41202020-05-05
00380740154233Alinity09P414009P41402020-05-05
00380740154240Alinity09P424009P42402020-01-02
00380740154516Alinity09P422009P42202020-01-02
00380740001339ARCHITECT1L76-0101L76012016-06-06
00380740001346ARCHITECT1L76-2501L76252016-06-06
00380740001353ARCHITECT1L76-5501L76552016-06-06
00380740001360ARCHITECT1L77-0101L77012016-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336147863Tina-quant Myoglobin Gen.2Roche Diagnostics GmbHDDR2020-08-21
00630414285047N Latex MyoglobinSiemens Healthcare Diagnostics Products GmbHDDR2020-05-29
00380740174903AlinityAbbott Ireland DiagnosticsDDR2019-07-08
00895160002496Fluoro-CheckTM AMI 3 in 1NANO-DITECH CORPORATIONDDR2019-05-24
30014613337157TriageQUIDEL CARDIOVASCULAR INC.DDR2018-11-01
30014613337164TriageQUIDEL CARDIOVASCULAR INC.DDR2018-11-01
30014613337911TriageQUIDEL CARDIOVASCULAR INC.DDR2018-11-01
30014613337959TriageQUIDEL CARDIOVASCULAR INC.DDR2018-11-01
00630414598468Atellica IM Calibrator USiemens Healthcare Diagnostics Inc.DDR2018-02-06
00630414599663Atellica IM MYOSiemens Healthcare Diagnostics Inc.DDR2018-02-06
00630414599670Atellica IM MYOSiemens Healthcare Diagnostics Inc.DDR2018-02-06
00630414599687Atellica IM MYO MCMSiemens Healthcare Diagnostics Inc.DDR2018-02-06
04015630940059Elecsys MyoglobinRoche Diagnostics GmbHDDR2017-04-21
04015630939541CalSet MyoglobinRoche Diagnostics GmbHDDR2017-04-17
00817089020610DiazymeDIAZYME LABORATORIES, INC.DDR2016-11-03
00817089020627DiazymeDIAZYME LABORATORIES, INC.DDR2016-11-03
00817089020634DiazymeDIAZYME LABORATORIES, INC.DDR2016-11-03
00895160002458Nano-CheckTM 4 in 1 TestNANO-DITECH CORPORATIONDDR2016-10-03
00899722002719Alere Triage®Alere San Diego, Inc.DDR2016-09-26
00899722002740Alere Triage®Alere San Diego, Inc.DDR2016-09-26
14560189210094ST AIA-PACK MyoglobinTOSOH CORPORATIONDDR2016-09-24
B176131Antiserum to Human MyoglobinKENT LABORATORIES INCDDR2016-09-24
04560189211018ST AIA-PACK Myoglobin CALIBRATOR SETTOSOH CORPORATIONDDR2016-09-24
04560189211025ST AIA-PACK Myoglobin SAMPLE DILUTING SOLUTIONTOSOH CORPORATIONDDR2016-09-24
05055273204681MYO CAL SETRANDOX LABORATORIES LIMITEDDDR2016-09-24
00842768004490Stratus® CS Acute Care™ CKMB TestPakSiemens Healthcare Diagnostics Inc.DDR2016-09-24
00842768004506Stratus® CS Acute Care™ CKMB CalPakSiemens Healthcare Diagnostics Inc.DDR2016-09-24
00842768004513Stratus® CS Acute Care™ CKMB DilPakSiemens Healthcare Diagnostics Inc.DDR2016-09-24
00842768004520Stratus® CS Acute Care™ cTNI TestPakSiemens Healthcare Diagnostics Inc.DDR2016-09-24
00842768004537Stratus® CS Acute Care™ cTNI CalPakSiemens Healthcare Diagnostics Inc.DDR2016-09-24