FDA.reportPublic FDA data

Na

Primary DI
05055273204704
Brand
Na
Company
RANDOX LABORATORIES LIMITED
Model
NA7167
Catalog number
NA7167
Device description
This product is intended for the quantitative in vitro determination of Sodium in serum and plasma
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEIUranyl Acetate/Zinc Acetate, Sodium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEIUranyl Acetate/Zinc Acetate, SodiumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043268000SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2Randox Laboratories, Ltd.2005-02-15CEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273204704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273204704050552732047045055273204704

GMDN Terms#

Term, Definition table
TermDefinition
Sodium (Na+) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of sodium (Na+) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00R1 Stable for 2 weeks at +2 to +8°C or 5 days at +15 to +25°C once opened. R2 Stable for 4 weeks at +2 to +8°C or 2 weeks at +15 to +25°C omce opened. CAL Stable when stored at 2-25°C
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03
05055273200034ALBAB3800AB38002016-09-16
05055273200041ALBAB362AB3622016-09-16
05055273200058ALBAB3800AB38002016-09-16
05055273208115ALBAB8301AB83012016-09-16
05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273203400GLUTATHIONE REDUCTASE (GLUT RED)GR23682019-06-03
05055273203417GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL)GR26082019-06-03
05055273203424GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL)GR26092019-06-03
05055273205091RABSRP3857RP38572016-09-26
05055273205893RX daytonaRX3900RX39002018-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486002188Teco Diagnostics Sodium Reagent SetTECO DIAGNOSTICSCEI2023-11-14
00657498000984Potassium TestSTANBIO LABORATORY, L.P.CEI2016-09-24
05055273204698NaRANDOX LABORATORIES LIMITEDCEI2016-09-16
05055273209310NaRANDOX LABORATORIES LIMITEDCEI2016-09-16