FDA.reportPublic FDA data

IMMULITE®/IMMULITE® 1000 Systems RMY Turbo Myoglobin

Primary DI
00630414964942
Brand
IMMULITE®/IMMULITE® 1000 Systems RMY Turbo Myoglobin
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10381020
Catalog number
LSKMY1
Device description
Myoglobin - IMMULITE - RGT - 100 Tests
Published
2016-09-24
Public version status
Update
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991796000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991796000IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5Diagnostic Products Corp.1999-06-09DDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414964942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414964942006304149649426304149649420630414964942

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)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
296822794
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414965017IMMULITE®/IMMULITE® 1000 Systems SUBS10385394LSUBX2020-09-24
00630414961125IMMULITE® 2000 Systems CEA10380995L2KCE62016-09-24
00630414964980IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH10381430LSKPTZ2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T410381635LKT452016-09-24
00630414972923IMMULITE®2000 Systems Diluent Tube Caps10385211L2ZC2020-09-24
00630414965734IMMULITE® 2000 Systems Allergen Tube Caps10282837L2ATC2020-09-24
00630414965741IMMULITE® 2000 Systems Allergen Tubes10282849L2ATS22020-09-24
00630414973159IMMULITE® 2000 Systems Diluent Tubes10385210L2ZT2020-09-24
00630414974064IMMULITE® 2000 Systems Microsampling Tube Caps10385205LSMC2020-09-24
00630414954547IMMULITE® 2000 Systems Reaction Tubes10385206LRXT2016-09-24
00630414973937IMMULITE® 2000 Systems Microsampling Tubes10385207LMST2016-09-24
00630414982403IMMULITE® 2000 XPi Sample Nesting Cups103741789052882016-09-24
00630414982410IMMULITE® 2000 Xpi Sample Nesting Cups103741799052892016-09-24
00630414961538IMMULITE® 2000 Systems IGF-110381448L2KGF22020-09-24
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04

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
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