FDA.reportPublic FDA data

RAPIDChem® 700 Lithium Sensor

Primary DI
00630414451862
Brand
RAPIDChem® 700 Lithium Sensor
Company
Siemens Healthcare Diagnostics Inc.
Model
10308981
Catalog number
583772
Device description
RAPIDChem® 700 Lithium Sensor for in vitro diagnostics use with the Rapidchem ® 700 systems
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
JGSELECTRODE, ION SPECIFIC, SODIUM
JIHFLAME PHOTOMETRY, LITHIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
JIHFlame Photometry, LithiumClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002407000EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZERMedica Corp.2001-02-02JGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414451862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414451862006304144518626304144518620630414451862

GMDN Terms#

Term, Definition table
TermDefinition
Lithium electrodeAn electrochemical sensor that preferentially responds as a potentiometric indicator to lithium ions.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 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

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00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
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