FDA.reportPublic FDA data

ST AIA-PACK Myoglobin SAMPLE DILUTING SOLUTION

Primary DI
04560189211025
Brand
ST AIA-PACK Myoglobin SAMPLE DILUTING SOLUTION
Company
TOSOH CORPORATION
Model
N/A
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
04560189211025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560189211025045601892110254560189211025

GMDN Terms#

Term, Definition table
TermDefinition
Myoglobin IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of myoglobin in a clinical specimen.

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
650-615-8134Dave.Wurtz@tosoh.com

Regulatory Flags#

DUNS number
690571724
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14560189212081ST AIA-PACK 27.29N/A2026-02-02
04560189213418ST AIA-PACK PROG II CALIBRATOR SETN/A2026-02-02
04560189210172ST AIA-PACK 27.29N/A2026-02-02
04560189213395ST AIA-PACK PROG II CALIBRATOR SETN/A2019-07-11
14560189210179ST AIA-PACK 27.29N/A2016-09-24
04560189283503G7 Beta-Thalassemia Elution Buffer KitN/A2016-09-24
14560189210339ST AIA-PACK TT3N/A2019-07-25
14560189212135ST AIA-PACK T-UN/A2019-07-25
04560189211742AIA-PACK SUBSTRATE SET IIn/a2019-09-02
04560189212220AIA-PACK C-Peptide Control SetN/A2019-09-02
04560189212749ST AIA-PACK hsE2 CALIBRATOR SETN/A2019-07-24
04560189211759AIA-PACK WASH CONCENTRATEN/A2019-09-02
04560189211766AIA-PACK DILUENT CONCENTRATEN/A2019-09-02
14560189210056AIA-PACK TSH 3rd-GenN/A2016-09-24
14560189210063ST AIA-PACK BetaHCGN/A2016-09-24
14560189210094ST AIA-PACK MyoglobinN/A2016-09-24
14560189210155ST AIA-PACK IgEIIN/A2016-09-24
14560189210230ST AIA-PACK AFPN/A2016-09-24
14560189210261ST AIA-PACK BMGN/A2016-09-24
14560189210315ST AIA-PACK FT4N/A2016-09-24

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
00380740174910AlinityAbbott Ireland DiagnosticsDDR2019-10-09
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
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