FDA.reportPublic FDA data

Electrolyte Standard Kit

Primary DI
00852553007162
Brand
Electrolyte Standard Kit
Company
VERICHEM LABORATORIES, INC.
Model
9200
Device description
Calibrator / calibration verifier
Published
2018-01-16
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
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112834000MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLESVerichem Laboratories, Inc.2012-03-28JIX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852553007162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852553007162008525530071628525530071620852553007162

GMDN Terms#

Term, Definition table
TermDefinition
Multiple electrolyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005525859customerservice@verichemlabs.com

Regulatory Flags#

DUNS number
189023351
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
00852553007049Enzymer Verifier Kit94302016-11-29
00852553007056Enzymer ER Verifier Kit94102016-11-29
00852553007131Enzymer ER Verifier, Level G94172016-11-29
00852553007001Total Protein/Albumin Standard Kit, Level F946694662016-11-15
00852553007018Matrix Plus Cholestereol Reference Kit95502016-11-29
00852553007025HDL Cholesterol Verifier Kit95602016-11-29
00852553007032Urine Uric Acid Standard Kit90202016-11-29
00852553007063Bilirubin Standard Kit94502016-11-29
00852553007070Bilirubin Standard, Level F94362016-11-29
00852553007087Ammonia / Iron Standard Kit90402016-11-29
00852553007094Serum ISE Standard Kit92402016-11-29
00852553007100Carbon Dioxide Standard Kit92102016-11-29
00852553007117BR2 Bilirubin Calibrator94592016-11-29
00852553007124Lipoprotein Verifier Kit95702016-11-29
00852553007148Matrix Plus Chemistry Reference Kit95002016-11-29
00852553007155Total Protein / Albumin Standard Kit94602016-12-05
00852553007179Urine Chemistry Standard Kit90002018-01-16
00852553007186LDL Cholesterol ExR Verifier Kit95802018-01-16
00852553007209Chemistry Reference Kit95102018-01-16
00852553007216Ammonia / Iron Standard, Level F90462018-01-16

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