FDA.reportPublic FDA data

RAPIDQC® Hct Level A

Primary DI
00630414121789
Brand
RAPIDQC® Hct Level A
Company
Siemens Healthcare Diagnostics Inc.
Model
10311392
Catalog number
570405
Device description
For in vitro diagnostic use for quality control of Hematocrit Analyzers.
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
GLKCONTROL, HEMATOCRIT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GLKControl, HematocritHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961807000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961807000CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4Ciba Corning Diagnostics Corp.1996-07-26GLK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414121789PrimaryGS10
00630414009339Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414121789006304141217896304141217890630414121789
00630414009339006304140093396304140093390630414009339

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 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
30
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24
00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
00630414008950ADVIA Chemistry P5PL_c Reagent10729782107297822021-11-04
00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
00630414513157ADVIA® Chemistry IRON_2 Reagents10341118103411182020-09-24
00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated10283341102833412020-09-24
00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
00630414224923ADVIA Cystatin C_2 Calibrator10734510107345102018-09-24
00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08426951293827ChemSTAT Hematocrit Evaluator 1INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
08426951293834ChemSTAT Hematocrit Evaluator 2INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
08426951293841ChemSTAT Hematocrit Evaluator 3INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
08426951293858GEM ChemSTAT critPVP 1-4INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
00831829000137HemataChek, Low, Normal, High ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000144HemataChek, Low & Normal ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000151HemataChek, Normal & High ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000168HemataChek Low Control SEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000182HemataChek Normal Control SEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000205HemataChek High ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00630414121796RAPIDQC® Hct Level BSiemens Healthcare Diagnostics Inc.GLK2016-09-24
08426950452058GEM critCheckINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950511526IL critPVPINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950046653Hct Check - Low LevelINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950046660Hct Check - High LevelINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950446231GEM CVP (Calibration Valuation Product) 3 HematocritINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950446248GEM CVP (Calibration Valuation Product) 4 HematocritINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950573661GEM Hematocrit Evaluator 1INSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950573678GEM Hematocrit Evaluator 2INSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950573685GEM Hematocrit Evaluator 3INSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
06944413801875Blood Gas and Chemistry AnalyzerEdan Instruments, Inc.GLK2016-09-01
06944413802018 Hematocrit ControlEdan Instruments, Inc.GLK2016-09-01
06944413802025Hematocrit ControlEdan Instruments, Inc.GLK2016-09-01
08718734960423EurotrolEurotrol B.V.GLK2016-08-26
08718734960430EurotrolEurotrol B.V.GLK2016-08-26
08718734960454EurotrolEurotrol B.V.GLK2016-08-26
08718734960478EurotrolEurotrol B.V.GLK2016-08-26