FDA.reportPublic FDA data

BUN/Polychem 180

Primary DI
00817439020291
Brand
BUN/Polychem 180
Company
Medtest Dx, Inc.
Model
BUN505
Catalog number
BUN505
Device description
For the quantitative determination of urea nitrogen in serum using the Polychem 180 analyzer. For in vitro diagnostic use only.6 x 51 ml, 4 x 20 ml
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972671000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972671000BUN (LIQUID) REAGENT SETPointe Scientific, Inc.,1997-07-20CDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817439020291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817439020291008174390202918174390202910817439020291

GMDN Terms#

Term, Definition table
TermDefinition
Urea IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen, using an enzyme spectrophotometry method. It is typically used as an indicator of kidney function and/or to differentiate between prerenal and postrenal azotemia.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-445-9853techservice@medtest.com

Regulatory Flags#

DUNS number
070371210
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
00817439020000Direct Lipid Control Set300030002016-09-27
00817439020017Direct Lipid Control L1300130012016-09-27
00817439020024Direct Lipid Control L2300230022016-09-27
00817439020031Direct Lipid Control L3300330032016-09-27
00817439020062Wash Concentrate 103W50003W5002016-09-27
00817439020079Wash Concentrate 209W50009W5002016-09-27
00817439020086Wash Concentrate 310W50010W5002016-09-27
00817439020093Albumin / BS480ALB480ALB4802016-09-27
00817439020109AlbuminALB505ALB5052016-09-27
00817439020116Albumin / BS200ALB600ALB6002016-09-27
00817439020123Alkaline Phos/ BS480ALP480ALP4802016-09-27
00817439020130ALP ReagentALP505ALP5052016-09-27
00817439020147MedTest DX Alkaline PhosphataseALP600ALP6002016-09-27
00817439020192Amylase / BS480AMY480AMY4802016-09-27
00817439020215Amylase / BS200AMY600AMY6002016-09-27
00817439020222AST / BS480AST480AST4802016-09-27
00817439020239AST / Polychem 180AST505AST5052016-09-27
00817439020246AST / BS200AST600AST6002016-09-27
00817439020314C1 Cleaning SolutionC1S500C1S5002016-09-27
00817439020321Calibrator Level 1 CA1100CA11002016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654119Atellica CH UN_cSiemens Healthcare Diagnostics Inc.CDQ2026-03-18
06944904084459Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.CDQ2026-01-23
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
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
00811727016058Pointe BUN ReagentHORIBA INSTRUMENTS INCORPORATEDCDQ2021-01-30
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
00852169008065ClearChem Diagnostics Inc. Blood Urea Nitrogen (BUN)CLEARCHEM DIAGNOSTICS INC.CDQ2018-04-30
00817274022672JAS DiagnosticsDREW SCIENTIFIC, INC.CDQ2018-04-26
00630414596471Atellica CH UN_cSiemens Healthcare Diagnostics Inc.CDQ2017-12-22
05060500091736Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091743Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091750Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091767Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091774Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091781Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28