FDA.reportPublic FDA data

Thermo Scientific

Primary DI
00845275003772
Brand
Thermo Scientific
Company
Fisher Diagnostics
Model
TS3000
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
JITCalibrator, Secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052148000TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SETReference Diagnostics, Inc.2005-11-09JIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275003772PrimaryGS10
00845275006308Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275003772008452750037728452750037720845275003772
00845275006308008452750063088452750063080845275006308

GMDN Terms#

Term, Definition table
TermDefinition
Total iron binding capacity (TIBC) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of total iron binding capacity (TIBC) of 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
6
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
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00630414622804Atellica IM CYFRA21-1 CalibratorSiemens Healthcare Diagnostics Inc.JIT2026-04-16
00816426021600K-ASSAY® Cystatin C CalibratorKAMIYA BIOMEDICAL COMPANY, LLCJIT2026-04-16
08058056685391Cystatin C CalibratorsSENTINEL CH. SPAJIT2025-09-16
14560189216331CL AIA-PACK Prolactin II ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14560189216638CL AIA-PACK hs-E2 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185395454CL AIA-PACK T3 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185399674CL AIA-PACK Progesterone ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185399728CL AIA-PACK LH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185400400CL AIA-PACK FSH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
00630414611204Atellica CH UAlb CALSiemens Healthcare Diagnostics Inc.JIT2025-08-11
04015630930609Preciset Lp(a) Gen.2Roche Diagnostics GmbHJIT2025-05-27
10758750034628VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
10758750035069VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
10758750034918VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-04-25
10758750032716VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-01-20
00811403011797ISE Calibrator LowDiamond Diagnostics Inc.JIT2023-06-05
00811403011810ISE Calibrator HighDiamond Diagnostics Inc.JIT2023-06-05
00811403013036Buffer PackDiamond Diagnostics Inc.JIT2023-06-05
00811403013180Buffer PackDiamond Diagnostics Inc.JIT2023-06-05
15099590702137Access Unconjugated Estriol CalibratorsBeckman Coulter, Inc.JIT2023-01-10
07613336166345CalSet beta-Amyloid (1-42) IIRoche Diagnostics GmbHJIT2022-12-13
00630414238708DM EXL LOCI BRAHMS PCT Cal KitSiemens Healthcare Diagnostics Inc.JIT2022-11-15
00630414610870Atellica CH LDLC CALSiemens Healthcare Diagnostics Inc.JIT2022-07-08
00630414600338Atellica™ IM VitDSiemens Healthcare Diagnostics Inc.JIT2021-05-28
00630414607047DV/DM COV2G/CV2G CALSiemens Healthcare Diagnostics Inc.JIT2021-01-22
14987481100999NEFA Standard SolutionFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIT2020-10-23
00630414293523Atellica IM Calibrator 30Siemens Healthcare Diagnostics Inc.JIT2020-05-31
00630414279190Atellica CH UCFP CalibratorSiemens Healthcare Diagnostics Inc.JIT2020-03-09