FDA.reportPublic FDA data

Thermo Scientific Infinity™

Primary DI
00845275000351
Brand
Thermo Scientific Infinity™
Company
Fisher Diagnostics
Model
TR12421
Published
2016-09-16
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973869000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973869000TRACE REAGENT LINE FOR THE COBAS MIRATrace America, Inc.1998-01-07CKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275000351PrimaryGS10
00845275006124Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275000351008452750003518452750003510845275000351
00845275006124008452750061248452750061240845275006124

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
800-528-0494xx@xx.xx

Regulatory Flags#

DUNS number
183998769
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845275002751Thermo Scientific Infinity™TR254212016-09-16
00845275000504Thermo Scientific Pacific Hemostasis®1003012016-09-16
00845275000559Thermo Scientific Pacific Hemostasis®1005952016-09-16
00845275000566Thermo Scientific Pacific Hemostasis®1005962016-09-16
00845275000573Thermo Scientific Pacific Hemostasis®1005972016-09-16
00845275000580Thermo Scientific Pacific Hemostasis®1006012016-09-16
00845275000634Thermo Scientific Pacific Hemostasis®1003082016-09-16
00845275000658Thermo Scientific Pacific Hemostasis®1003122016-09-16
00845275000818Thermo Scientific Pacific Hemostasis®1005602016-09-16
00845275000832Thermo Scientific Pacific Hemostasis®1006032016-09-16
00845275000849Thermo Scientific Pacific Hemostasis®1006062016-09-16
00845275000016Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers OSR611542025-11-18
00845275000405Thermo Scientific TR360262016-09-16
00845275001068Thermo Scientific 12452502016-09-16
00845275002973Thermo Scientific TR333212016-09-16
00845275005431Thermo Scientific for Beckman Coulter SYNCHRON and UnuCel SystemsA466602016-09-16
00845275004717Thermo Scientific Nerl®JDIL55222019-08-13
00845275003031Thermo Scientific Infinity™TR351212016-09-16
00845275000528Thermo Scientific Pacific Hemostasis®1003532016-09-16
00845275000535Thermo Scientific Pacific Hemostasis®1003542016-09-16

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