FDA.reportPublic FDA data

BR2 Bilirubin Calibrator

Primary DI
00852553007117
Brand
BR2 Bilirubin Calibrator
Company
VERICHEM LABORATORIES, INC.
Model
9459
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
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
00852553007117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852553007117008525530071178525530071170852553007117

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry protein IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

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
00852553007100Carbon Dioxide Standard Kit92102016-11-29
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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