FDA.reportPublic FDA data

RAPIDChem® 744 Na+K+Cl- Reagent Module

Primary DI
00630414451817
Brand
RAPIDChem® 744 Na+K+Cl- Reagent Module
Company
Siemens Healthcare Diagnostics Inc.
Model
10309048
Catalog number
2970609
Device description
RAPIDChem® 744 Na+K+Cl- Reagent Module for in vitro diagnostics use with the Rapidchem® 744 system.
Published
2016-09-24
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
CEMELECTRODE, ION SPECIFIC, POTASSIUM
CGZELECTRODE, ION-SPECIFIC, CHLORIDE
JGSELECTRODE, ION SPECIFIC, SODIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000926000EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZERMedica Corp.2000-05-15CGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414451817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414451817006304144518176304144518170630414451817

GMDN Terms#

Term, Definition table
TermDefinition
Multiple electrolyte IVD, kit, ion-selective electrode (ISE)A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen, using an ion-selective electrode (ISE) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
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
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

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Primary DI, Brand, Company table
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10054749005519i-STATABBOTT POINT OF CARE INC.JGS2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CGZ2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CEM2020-05-01
00380740156855ARCHITECTABBOTT LABORATORIESCEM2019-10-31
00380740156855ARCHITECTABBOTT LABORATORIESJGS2019-10-31
00380740163372ARCHITECTAbbott GmbHCEM2019-08-15
00380740163372ARCHITECTAbbott GmbHJGS2019-08-15
00380740121686AlinityAbbott GmbHCGZ2018-05-30
00380740121686AlinityAbbott GmbHJGS2018-05-30
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