FDA.reportPublic FDA data

Thermo Scientific

Primary DI
00845275002997
Brand
Thermo Scientific
Company
Fisher Diagnostics
Model
TR34026
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
CEKBiuret (Colorimetric), Total Protein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEKBiuret (Colorimetric), Total ProteinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K870371000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K870371000TOTAL PROTEIN REAGENT - BIURET METHODTrace Scientific , Ltd.1987-08-19CEK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275002997PrimaryGS10
00845275006216Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275002997008452750029978452750029970845275002997
00845275006216008452750062168452750062160845275006216

GMDN Terms#

Term, Definition table
TermDefinition
Total protein 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 quantitative measurement of total protein in a clinical specimen.

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
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
00845275000542Thermo Scientific Pacific Hemostasis®1003562016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654010Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2026-03-18
00850053916144IDG/SanzayIDG/SANZAY CorporationCEK2024-01-12
00630414611082Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2023-12-13
00630414306025Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2023-12-13
10673486002171Teco Diagnostics CSF/Urine Protein Reagent SetTECO DIAGNOSTICSCEK2023-11-14
10673486002201Teco Diagnostics Total Protein Reagent SetTECO DIAGNOSTICSCEK2023-11-14
10673486002218Teco Diagnostics Total Protein Reagent Kit for TC-MatrixTECO DIAGNOSTICSCEK2023-11-14
06971674862215BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862222BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862239BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862246BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862253BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862260BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862277BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862284BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862291BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862307BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862314BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862321BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862338BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862352BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862369BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862376BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862383BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
05055273206531TOTAL PROTEIN (TP)RANDOX LABORATORIES LIMITEDCEK2022-10-05
05055273206555TOTAL PROTEIN (TP)RANDOX LABORATORIES LIMITEDCEK2022-10-05
05055273206562TOTAL PROTEIN 2 (TP 2)RANDOX LABORATORIES LIMITEDCEK2022-10-05
00380740155469ARCHITECTABBOTT IRELANDCEK2022-07-12
00380740155476ARCHITECTABBOTT IRELANDCEK2022-07-12
00380740155261AlinityABBOTT IRELANDCEK2022-06-30