FDA.reportPublic FDA data

Tru-Zero Bilirubin Standard

Primary DI
00852553007308
Brand
Tru-Zero Bilirubin Standard
Company
VERICHEM LABORATORIES, INC.
Model
9456
Device description
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
JITCalibrator, Secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K882059000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K882059000BILIRUBIN STANDARDVerichem Laboratories, Inc.1988-10-25JIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852553007308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852553007308008525530073088525530073080852553007308

GMDN Terms#

Term, Definition table
TermDefinition
Conjugated (direct) bilirubin IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of conjugated (direct) bilirubin in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-552-5859customerservice@verichemlabs.com

Regulatory Flags#

DUNS number
189023351
Device count
1
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
00852553007162Electrolyte Standard Kit92002018-01-16
00852553007179Urine Chemistry Standard Kit90002018-01-16
00852553007186LDL Cholesterol ExR Verifier Kit95802018-01-16
00852553007209Chemistry Reference Kit95102018-01-16

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