FDA.reportPublic FDA data

Urea Nitrogen / Creatinine Standard Kit

Primary DI
00852553007384
Brand
Urea Nitrogen / Creatinine Standard Kit
Company
VERICHEM LABORATORIES, INC.
Model
9090
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
JISCalibrator, Primary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901113000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901113000MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARDVerichem Laboratories, Inc.1990-03-29JIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852553007384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852553007384008525530073848525530073840852553007384

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.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10758750033539VITROSORTHO CLINICAL DIAGNOSTICSJIS2025-12-30
15099590754495Access Total T4 II CalibratorsBeckman Coulter, Inc.JIS2025-09-19
10758750035373VITROSORTHO CLINICAL DIAGNOSTICSJIS2025-05-20
20758750035370VITROSORTHO CLINICAL DIAGNOSTICSJIS2025-05-20
05051700020534Optilite® Low Level Total Protein CalibratorTHE BINDING SITE GROUP LIMITEDJIS2024-10-30
00816426021532K-ASSAY® RF Calibrator (Ver.2)KAMIYA BIOMEDICAL COMPANY, LLCJIS2024-04-17
00630414615097Atellica CH Billirubin Calibrator (BILI CAL)Siemens Healthcare Diagnostics Inc.JIS2024-04-03
00630414313450Atellica CH Billirubin Calibrator (BILI CAL)Siemens Healthcare Diagnostics Inc.JIS2024-04-03
00630414639833INNOVANCE Heparin CalibratorSiemens Healthcare Diagnostics Products GmbHJIS2024-03-25
15099590752699Access Progesterone II CalibratorsBeckman Coulter, Inc.JIS2024-03-01
00630414611297Atellica CH RCRP CalSiemens Healthcare Diagnostics Inc.JIS2024-02-02
00630414636672Atellica CH Protein 1 Calibrator (PROT 1 CAL)Siemens Healthcare Diagnostics Inc.JIS2024-02-02
00630414305141Atellica CH RCRP CalSiemens Healthcare Diagnostics Inc.JIS2024-02-02
00630414313467Atellica CH Protein 1 Calibrator (PROT 1 CAL)Siemens Healthcare Diagnostics Inc.JIS2024-02-02
10758750034635VITROSORTHO CLINICAL DIAGNOSTICSJIS2024-01-20
20758750034632VITROSORTHO CLINICAL DIAGNOSTICSJIS2024-01-20
00380740197636AlinityAbbott GmbHJIS2023-11-04
07613336203538Anti-Tg CalSetRoche Diagnostics GmbHJIS2023-10-31
07613336175088CalSet FT4 IVRoche Diagnostics GmbHJIS2023-05-02
10758750033799VITROSORTHO CLINICAL DIAGNOSTICSJIS2023-03-28
10758750033850VITROSORTHO CLINICAL DIAGNOSTICSJIS2023-03-28
03607360047606CDT CAPILLARYS CALIBRATORS (2 Levels)SEBIAJIS2022-12-12
03607360047613CDT MINICAP CALIBRATORS ( 2 Levels)SEBIAJIS2022-12-12
10758750034642VITROSORTHO CLINICAL DIAGNOSTICSJIS2022-10-26
10758750034659VITROSORTHO CLINICAL DIAGNOSTICSJIS2022-10-24
10758750034895VITROSORTHO CLINICAL DIAGNOSTICSJIS2022-10-24
05055273204445LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3) RANDOX LABORATORIES LIMITEDJIS2022-10-05
00817302024340CAROLINA LIQUID CHEMISTRIES CORP.® IRON STANDARD (FESTD) CC618-STDCAROLINA LIQUID CHEMISTRIES CORPORATIONJIS2022-08-19
00630414610863Atellica CH HDLC CALSiemens Healthcare Diagnostics Inc.JIS2022-07-08
00630414305165Atellica CH HDLC CALSiemens Healthcare Diagnostics Inc.JIS2022-07-08