FDA.reportPublic FDA data

Thermo Scientific Infinity™

Primary DI
00845275003239
Brand
Thermo Scientific Infinity™
Company
Fisher Diagnostics
Model
TR50001
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
JGQTurbidimetric, Total Protein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGQTurbidimetric, Total ProteinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925794000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925794000TRACE MICROPROTEIN REAGENTTrace America, Inc.1993-03-29JGQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275003239PrimaryGS10
00845275006247Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275003239008452750032398452750032390845275003239
00845275006247008452750062478452750062470845275006247

GMDN Terms#

Term, Definition table
TermDefinition
Total protein IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total protein in a clinical specimen, using an enzyme 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
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
00380740161798ARCHITECTAbbott GmbHJGQ2020-04-18
00380740161804ARCHITECTAbbott GmbHJGQ2020-04-18
07613336121535Total Protein Urine/CSF Gen.3Roche Diagnostics GmbHJGQ2020-03-05
00380740135317AlinityAbbott GmbHJGQ2019-05-07
00380740135300AlinityAbbott GmbHJGQ2018-11-07
04015630919536Total Protein UrineCSF Gen3Roche Diagnostics GmbHJGQ2016-09-20
04015630925179Total Protein UrineCSF Gen3Roche Diagnostics GmbHJGQ2016-09-20
04015630936441Protein Total Protein in UrineCerebrospinal FluidRoche Diagnostics GmbHJGQ2016-09-20
00380740013028ARCHITECTABBOTT LABORATORIESJGQ2016-09-09
00380740013035ARCHITECTABBOTT LABORATORIESJGQ2016-06-06