FDA.reportPublic FDA data

Thermo Scientific

Primary DI
00845275000405
Brand
Thermo Scientific
Company
Fisher Diagnostics
Model
TR36026
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
CIXBromcresol Green Dye-Binding, Albumin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIXBromcresol Green Dye-Binding, AlbuminClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K870372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K870372000ALBUMIN REAGENT - BROMCRESOL GREEN METHODTrace Scientific , Ltd.1987-08-19CIX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275000405PrimaryGS10
00845275006230Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275000405008452750004058452750004050845275000405
00845275006230008452750062308452750062300845275006230

GMDN Terms#

Term, Definition table
TermDefinition
Albumin IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of albumin in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 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
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
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
00845275000542Thermo Scientific Pacific Hemostasis®1003562016-09-16
00845275000795Thermo Scientific Pacific Hemostasis®1003572016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654140Atellica CH AlbSiemens Healthcare Diagnostics Inc.CIX2026-03-18
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
00380740155346AlinityABBOTT IRELANDCIX2024-08-15
00380740155353AlinityABBOTT IRELANDCIX2024-08-15
00380740155872ARCHITECTABBOTT IRELANDCIX2024-08-15
00380740155889ARCHITECTABBOTT IRELANDCIX2024-08-15
00850053916007IDG/SanzayIDG/SANZAY CorporationCIX2023-12-18
10673486001013Albumin Reagent SetTECO DIAGNOSTICSCIX2023-07-07
10673486001020Albumin -BCG method TC-MatrixTECO DIAGNOSTICSCIX2023-07-07
00811727016003Pointe Albumin Reagent HORIBA INSTRUMENTS INCORPORATEDCIX2021-01-30
00811727015693Pointe Albumin on BS480 AnalyzerHORIBA INSTRUMENTS INCORPORATEDCIX2020-05-28
10758750031771VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CIX2020-05-16
03610230006825Yumizen C1200 AlbuminHORIBA ABX SASCIX2020-05-06
07613336120941Albumin Gen.2Roche Diagnostics GmbHCIX2020-03-05
07613336120958Albumin Gen.2Roche Diagnostics GmbHCIX2020-03-05
00380740161644ARCHITECTAbbott GmbHCIX2019-11-15
00386100002145ALB Reagent KitMEDICA CORPORATIONCIX2019-02-14
00380740121716AlinityAbbott GmbHCIX2018-07-11
00852169008010ClearChem Diagnostics Inc. AlbuminCLEARCHEM DIAGNOSTICS INC.CIX2018-04-30
00817274022696JAS DiagnosticsDREW SCIENTIFIC, INC.CIX2018-04-26
00630414596501Atellica CH AlbSiemens Healthcare Diagnostics Inc.CIX2017-12-22
05060500091682Synermed®INFRARED LABORATORY SYSTEMS LLCCIX2017-02-28
00817302022957CAROLINA LIQUID CHEMISTRIES CORP.® ALB REAGENT PRODUCT NO. DT224CAROLINA LIQUID CHEMISTRIES CORPORATIONCIX2016-10-17
00812137011848Albumin ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIX2016-10-12
00081213701184Albumin ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIX2016-10-12
00817274022313JAS DiagnosticsDREW SCIENTIFIC, INC.CIX2016-10-11
00817439020093Albumin / BS480Medtest Dx, Inc.CIX2016-09-27