FDA.reportPublic FDA data

Thermo Scientific Infinity™

Primary DI
00845275001082
Brand
Thermo Scientific Infinity™
Company
Fisher Diagnostics
Model
1265250
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
CJYAzo Dye, Calcium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJYAzo Dye, CalciumClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275001082PrimaryGS10
00845275005936Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275001082008452750010828452750010820845275001082
00845275005936008452750059368452750059360845275005936

GMDN Terms#

Term, Definition table
TermDefinition
Calcium (Ca2+) 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 calcium (Ca2+) 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
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
03610230008607Yumizen C1200 Calcium ASHORIBA ABX SASCJY2020-05-06
00380740161491ARCHITECTAbbott GmbHCJY2020-03-09
00380740161507ARCHITECTAbbott GmbHCJY2020-03-09
00380740161514ARCHITECTAbbott GmbHCJY2020-03-09
10758750031795VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CJY2019-11-13
05055273208368CALCIUM (Ca)RANDOX LABORATORIES LIMITEDCJY2019-06-03
00386100002060Ca Reagent Kit MEDICA CORPORATIONCJY2019-02-14
00630414220697Atellica CH CA_2Siemens Healthcare Diagnostics Inc.CJY2018-09-24
00380740135409AlinityAbbott GmbHCJY2018-08-31
00380740132613AlinityAbbott GmbHCJY2018-08-08
00817274022450JAS DiagnosticsDREW SCIENTIFIC, INC.CJY2017-04-04
05060500091835Synermed®INFRARED LABORATORY SYSTEMS LLCCJY2017-02-28
00817302023091CAROLINA LIQUID CHEMISTRIES CORP.® CA REAGENT PRODUCT NO. DT251CAROLINA LIQUID CHEMISTRIES CORPORATIONCJY2016-10-17
15099590000325AUBeckman Coulter, Inc.CJY2016-09-24
15099590011086AUBeckman Coulter, Inc.CJY2016-09-24
15099590060183AUBeckman Coulter, Inc.CJY2016-09-24
00857969006105ACEALFA WASSERMANN, INC.CJY2016-09-24
00630414513096ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III)Siemens Healthcare Diagnostics Inc.CJY2016-09-24
00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)Siemens Healthcare Diagnostics Inc.CJY2016-09-24
00630414553160ADVIA® Chemistry CA_2c Calcium_2 Reagents, Concentrated - Arsenazo IIISiemens Healthcare Diagnostics Inc.CJY2016-09-24
EABA40000241Piccolo Basic Metabolic PanelABAXIS, INC.CJY2016-09-23
EABA40000271Piccolo Renal Function PanelABAXIS, INC.CJY2016-09-23
EABA40000281Piccolo Comprehensive Metabolic PanelABAXIS, INC.CJY2016-09-23
EABA40000291Piccolo General Chemistry 13ABAXIS, INC.CJY2016-09-23
EABA40000311Piccolo Basic Metabolic Panel PlusABAXIS, INC.CJY2016-09-23
EABA40000351Piccolo BioChemistry Panel PlusABAXIS, INC.CJY2016-09-23
EABA40000371Piccolo MetLac 12 PanelABAXIS, INC.CJY2016-09-23
EABA40000411Piccolo AmLyte 13ABAXIS, INC.CJY2016-09-23
00657498000618Calcium (Arsenazo) LiquiColor®STANBIO LABORATORY, L.P.CJY2016-09-23
00657498001462Sirrus® Calcium LiquiColor®STANBIO LABORATORY, L.P.CJY2016-09-23