FDA.reportPublic FDA data

ClearChem Diagnostics Inc. Blood Urea Nitrogen (BUN)

Primary DI
00852169008065
Brand
ClearChem Diagnostics Inc. Blood Urea Nitrogen (BUN)
Company
CLEARCHEM DIAGNOSTICS INC.
Model
BUN1070
Catalog number
BUN1070
Device description
In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL
Published
2018-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDQUREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDQUrease And Glutamic Dehydrogenase, Urea NitrogenClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852169008065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852169008065008521690080658521690080650852169008065

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume225Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Refrigerated
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(714)734-8041dwheat@clearchem.net

Regulatory Flags#

DUNS number
010655581
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00852169008126ClearChem Diagnostics Inc. Creatinine (Jaffe)CRE1120CRE11202018-04-30
00852169008171ClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP)CRP1320CRP13202018-04-30
00852169008201ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) CholesterolLDL1230LDL12302018-05-18
00852169008294ClearChem Diagnostics Inc. MicroProtein, TotalMPN2020MPN20202018-06-08
00852169008232ClearChem Diagnostics Inc. TIBC-DirectITI1160ITI11602018-05-22
00852169008270ClearChem Diagnostics Inc. MicroAlbuminMAL1010MAL10102018-05-22
00852169008287ClearChem Diagnostics Inc. Hemoglobin A-1cHGB1200HGB12002018-05-22
00852169008058ClearChem Diagnostics Inc. Aspartate aminotransferase (AST)AST1040AST10402018-05-18
00852169008164ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) CholesterolHDL1210HDL12102018-05-18
00852169008072ClearChem Diagnostics Inc. Carbon Dioxide (CO2)CAR1090CAR10902018-04-30
00852169008027ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP)ALP1010ALP10102018-04-30
00852169008034ClearChem Diagnostics Inc. Alanine aminotransferase (ALT)ALT1020ALT10202018-04-30
00852169008041ClearChem Diagnostics Inc. AmylaseAMY1030AMY10302018-04-30
00852169008089ClearChem Diagnostics Inc. Creatine Kinase (CK)CPK1110CPK11102018-04-30
00852169008096ClearChem Diagnostics Inc. Bilirubin, DirectBRD1050BRD10502018-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
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10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
00850053916069IDG/SanzayIDG/SANZAY CorporationCDQ2024-01-09
10673486001228Teco Diagnostics Urea Nitrogen (BUN) Liquid Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
10673486001235Teco Diagnostics BUN (Urea) Reagent Kit TC Matrix-240/480TECO DIAGNOSTICSCDQ2023-07-21
10673486001242Teco Diagnostics Urea Nitrogen (BUN) Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
10673486001259Teco Diagnostics Urea Nitrogen (BUN) Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
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03610230007211Yumizen C1200 UreaHORIBA ABX SASCDQ2020-08-28
00811727015747Pointe BUN on BS480HORIBA INSTRUMENTS INCORPORATEDCDQ2020-05-28
07613336121603Urea/BunRoche Diagnostics GmbHCDQ2020-03-05
00380740161774ARCHITECTAbbott GmbHCDQ2020-01-25
00380740161781ARCHITECTAbbott GmbHCDQ2020-01-25
05055273216172UREARANDOX LABORATORIES LIMITEDCDQ2019-06-03
00386100001988BUN Reagent Kit MEDICA CORPORATIONCDQ2019-02-14
00380740121662AlinityAbbott GmbHCDQ2018-08-31
00380740121679AlinityAbbott GmbHCDQ2018-08-31
00817274022672JAS DiagnosticsDREW SCIENTIFIC, INC.CDQ2018-04-26
00630414596471Atellica CH UN_cSiemens Healthcare Diagnostics Inc.CDQ2017-12-22
05060500091736Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
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05060500091781Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
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