FDA.reportPublic FDA data

Carbon Dioxide Standard Kit

Primary DI
00852553007100
Brand
Carbon Dioxide Standard Kit
Company
VERICHEM LABORATORIES, INC.
Model
9210
Device description
Calibrator / Calibration Verifier
Published
2016-11-29
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
00852553007100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852553007100008525530071008525530071000852553007100

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide (CO2) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of bicarbonate (HCO3-) ions [as a measure of carbon dioxide (CO2) concentration] in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume75Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-552-5859customerservice@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
00852553007117BR2 Bilirubin Calibrator94592016-11-29
00852553007124Lipoprotein Verifier Kit95702016-11-29
00852553007148Matrix Plus Chemistry Reference Kit95002016-11-29
00852553007155Total Protein / Albumin Standard Kit94602016-12-05
00852553007162Electrolyte Standard Kit92002018-01-16
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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