FDA.reportPublic FDA data

BUN Reagent, Liquid

Primary DI
00817238011193
Brand
BUN Reagent, Liquid
Company
CLINIQA CORPORATION
Model
R84533
Device description
BUN Reagent, Liquid
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CDGChromatography Separation/Zimmerman 17-Ketogenic Steroids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDGChromatography Separation/Zimmerman 17-Ketogenic SteroidsClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012649000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012649000RAICHEM BUN RATE REAGENTHemagen Diagnostics, Inc.2001-10-15CDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817238011193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817238011193008172380111938172380111930817238011193

GMDN Terms#

Term, Definition table
TermDefinition
Urea IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078742335
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817238010257LiquidQC NEPHROCHECK Control 839382024-06-05
00817238010332NEPHROCHECK Calibration Verification839392024-06-05
00817238010264NEPHROCHECK® Method Validation For VIDAS® 3839402019-01-29
00817238010271LIQUID QC LIPID CONTROL LEVEL 915012018-08-23
00817238010288LIQUID QC LIPID CONTROL LEVEL 2 915022018-08-23
00817238010295LIQUID QC LIPID CONTROL Bi-level 915052018-08-23
00817238011520LQC Cardiac Control CS, mini pack914492022-11-19
00817238011056hsCRP Wide Range Reagent855502018-08-23
00817238010103Tumor Marker Control level 3913032018-08-22
00817238010110Tumor Marker Control level 1 913012018-08-22
00817238010127Tumor Marker Control level 2913022018-08-22
00817238010134Tumor Marker Control Tri-level913042018-08-22
00817238010141ImmuTROL Serum Protein Contrl Tri-Level (Level 1,2 & 3)911042018-08-22
00817238010158Tumor Marker Control Tri-level913092018-08-22
00817238010172ImmuTROL Serum Protein Control-Bi-Level (Level 1 & 3)911052018-08-22
00817238010189ImmuTROL Serum Protein Contrl Level 1911012018-08-22
00817238010196ImmuTROL Serum Protein Contrl Level 2911022018-08-22
00817238010202ImmuTROL Serum Protein Contrl Level 3911032018-08-22
00817238010219hsCRP Serum Protein Control Level 1912012018-08-22
00817238010226hsCRP Serum Protein Control Level 2912022018-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04946329404234Short Boot ExtenderMIZUHO CORPORATIONCDG2025-06-10
00810143904802SURGIPROSSurgipros, LLCCDG2024-07-11
10889981178239Mariner MISSeaspine Orthopedics CorporationCDG2024-03-06
07332339232597imagiQStille ABCDG2021-03-12
07332339232610imagiQStille ABCDG2021-03-12
00817238011391BUN Rate ReagentCLINIQA CORPORATIONCDG2016-09-21