FDA.reportPublic FDA data

Atellica IM MYO

Primary DI
00630414599670
Brand
Atellica IM MYO
Company
Siemens Healthcare Diagnostics Inc.
Model
10995649
Catalog number
10995649
Device description
Myoglobin (MYO) Atellica IM - RGT 50T
Published
2018-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974325000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974325000CHIRON DIAGNOSTICS ACS:180 MYOGLOBINChiron Diagnostics Corp.1997-12-08DDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414599670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414599670006304145996706304145996700630414599670

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
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

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
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