FDA.reportPublic FDA data

RAPIDQC® Hct Level B

Primary DI
00630414121796
Brand
RAPIDQC® Hct Level B
Company
Siemens Healthcare Diagnostics Inc.
Model
10311393
Catalog number
570406
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
00630414121796PrimaryGS10
00630414009346Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414121796006304141217966304141217960630414121796
00630414009346006304140093466304140093460630414009346

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
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
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
00630414121789RAPIDQC® Hct Level ASiemens 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