FDA.reportPublic FDA data

Thermo Scientific Infinity™ for Olympus Analyzers

Primary DI
00845275003345
Brand
Thermo Scientific Infinity™ for Olympus Analyzers
Company
Fisher Diagnostics
Model
TR66002
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
NDWAssay, Porphyrin, Spectrophotometry, Lithium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDWAssay, Porphyrin, Spectrophotometry, LithiumClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003583000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003583000LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901Trace America, Inc.2001-01-17NDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275003345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275003345008452750033458452750033450845275003345

GMDN Terms#

Term, Definition table
TermDefinition
Lithium therapeutic drug monitoring 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 and therapeutic monitoring of the central nervous system drug lithium in a clinical specimen.

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
1
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
00811403010691Lithium ElectrodeDiamond Diagnostics Inc.NDW2023-06-05
00630414287935Atellica CH Lithium_2 (LITH_2)Siemens Healthcare Diagnostics Inc.NDW2020-11-27
00630414288178ADVIA Chemistry Lithium_2 (LITH_2) reagentsSiemens Healthcare Diagnostics Inc.NDW2020-11-27
07613336121382LithiumRoche Diagnostics GmbHNDW2020-03-05
00380740136277AlinityABBOTT LABORATORIESNDW2018-07-30
00630414006789Atellica CH LiSiemens Healthcare Diagnostics Inc.NDW2017-12-21
00385480167291NOVANOVA BIOMEDICAL CORPORATIONNDW2017-04-24
00842768035326Dimension Vista® Flex® reagent cartridge LITHSiemens Healthcare Diagnostics Inc.NDW2016-09-24
00630414509778ADVIA® Chemistry LITH Lithium ReagentsSiemens Healthcare Diagnostics Inc.NDW2016-09-24
00385480152112NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480152129NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480157421NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480539630NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480539647NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
04015630921669LithiumRoche Diagnostics GmbHNDW2016-09-20
04015630032440Lithium ElectrodeRoche Diagnostics GmbHNDW2016-09-20
00385480128827NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480131940NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480132039NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480136839NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480139847NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480140829NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480141826NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480141871NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480142441NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
10385480152126NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
10385480157428NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480165013NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480167284NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
05055273209143Li 2RANDOX LABORATORIES LIMITEDNDW2016-09-16