FDA.report

ST AIA-PACK Myoglobin CALIBRATOR SET

Primary DI
04560189211018
Brand
ST AIA-PACK Myoglobin CALIBRATOR SET
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
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DDRMyoglobin, Antigen, Antiserum, Control

Product Code Classifications

CodeDeviceSpecialtyClass
DDRMyoglobin, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04560189211018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04560189211018045601892110184560189211018

GMDN Terms

TermDefinition
Myoglobin IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of myoglobin in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
614-317-1909Levent.durukan@tosoh.com
650-615-8134Dave.Wurtz@tosoh.com

Regulatory Flags

DUNS number
690571724
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04560189213418ST AIA-PACK PROG II CALIBRATOR SETN/A2026-02-02
04560189210172ST AIA-PACK 27.29N/A2026-02-02
04560189283923Hemoglobin A1c Control SetN/A2026-01-05
04562185400571HbA1c Diluting SolutionN/A2026-01-05
04562185403060HbA1c Calibrator Set (S)N/A2026-01-05
04562185404920Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01HLC-723GR012026-01-05
0456218540493790 Sample Loader GR-90SL2026-01-05
04562185404944290 Sample LoaderGR-290SL2026-01-05
04562185405255TSKgel GR01 HbA1c ColumnN/A2026-01-05
14562185405269GR01 HbA1c Elution Buffer No. 1N/A2026-01-05
14562185405276GR01 HbA1c Elution Buffer No. 2N/A2026-01-05
14562185405283GR01 HbA1c Elution Buffer No. 3N/A2026-01-05
04562185406207Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LAHLC-723GR01LA2026-01-05
24560189216321CL AIA-PACK Prolactin II TEST CUPN/A2025-09-01
24560189216338CL AIA-PACK Prolactin II ADJUSTER SETN/A2025-09-01
24560189216628CL AIA-PACK hs-E2 TEST CUPN/A2025-09-01
24560189216635CL AIA-PACK hs-E2 ADJUSTER SETN/A2025-09-01
24562185395390CL AIA-PACK SAMPLE DILUTING REAGENT AN/A2025-09-01
24562185395444CL AIA-PACK T3 TEST CUPN/A2025-09-01
24562185395451CL AIA-PACK T3 ADJUSTER SETN/A2025-09-01

Other Devices Sharing Product Codes

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
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
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
14560189210094ST AIA-PACK MyoglobinTOSOH CORPORATIONDDR2016-09-24
B176131Antiserum to Human MyoglobinKENT LABORATORIES INCDDR2016-09-24
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
00842768004605Stratus® CS Acute Care™ MYO TestPakSiemens Healthcare Diagnostics Inc.DDR2016-09-24
00842768012808N Latex MyoglobinSiemens Healthcare Diagnostics Products GmbHDDR2016-09-24
00842768013843Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge MYOSiemens Healthcare Diagnostics Inc.DDR2016-09-24
00842768015335Dimension Vista® Flex® reagent cartridge MYOSiemens Healthcare Diagnostics Inc.DDR2016-09-24
00630414000190ADVIA® Chemistry MYO Myoglobin ReagentsSiemens Healthcare Diagnostics Inc.DDR2016-09-24
00630414178493ADVIA Centaur® ACS:180® Calibrator USiemens Healthcare Diagnostics Inc.DDR2016-09-24
00630414180014ADVIA Centaur® MYO MCMSiemens Healthcare Diagnostics Inc.DDR2016-09-24
00630414197180ADVIA Centaur® MYOSiemens Healthcare Diagnostics Inc.DDR2016-09-24
00630414197197ADVIA Centaur® MYO +USiemens Healthcare Diagnostics Inc.DDR2016-09-24
00630414961736IMMULITE® 2000 Systems MYO MyoglobinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDDR2016-09-24
00630414964270IMMULITE®/IMMULITE® 1000 Systems MYO MyoglobinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDDR2016-09-24