FDA.reportPublic FDA data

Thermo Scientific Pacific Hemostasis®

Primary DI
00845275000528
Brand
Thermo Scientific Pacific Hemostasis®
Company
Fisher Diagnostics
Model
100353
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
GJSTest, Time, Prothrombin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJSTest, Time, ProthrombinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940082000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940082000THROMBOSCREEN THROMBOPLASTIN-DSPacific Hemostasis1995-02-14GJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275000528PrimaryGS10
00845275005585Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275000528008452750005288452750005280845275000528
00845275005585008452750055858452750055850845275005585

GMDN Terms#

Term, Definition table
TermDefinition
Prothrombin time (PT) IVD, kit, clotting, rapidA collection of reagents and other associated materials intended to be used for the semi-quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR), within a short period relative to standard laboratory testing procedures using a clotting method. This test is commonly used in the laboratory or in point-of-care analyses.

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
10
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
00845275000535Thermo Scientific Pacific Hemostasis®1003542016-09-16
00845275000542Thermo Scientific Pacific Hemostasis®1003562016-09-16
00845275000795Thermo Scientific Pacific Hemostasis®1003572016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436540291141microINR® Expert KitILINE MICROSYSTEMS SLGJS2026-04-22
09360136000079 Xprecia Prime™ Coagulation AnalyzerUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
09360136000086 Xprecia Prime™ Coagulation AnalyzerUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
09360136000093Xprecia Prime™ PT/INR Test StripsUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
08436540291134microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-08-02
08436540290915microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-08-02
00850053916205IDG/SanzayIDG/SANZAY CorporationGJS2024-07-03
08436540290908microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-04-01
00630414639871Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414639888Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414639963Thromborel SSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414640006Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019593Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019609Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768018749Thromborel SSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019586Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00850053916182IDG/SanzayIDG/SANZAY CorporationGJS2024-01-12
00054749004782i-STAT PTplus CartridgeAbbott Point of Care Inc.GJS2024-01-10
00054749004843i-STAT PTplus Control Level 1Abbott Point of Care Inc.GJS2024-01-10
00054749004850i-STAT PTplus Control Level2Abbott Point of Care Inc.GJS2024-01-10
00365702702356CoaguChek VantusRoche Diagnostics GmbHGJS2023-12-01
00850040656022Assure PT Care PT/INR Monitoring System COAGUSENSE INC.GJS2023-04-06
00850040656039Assure PT Care Test Strip KitCOAGUSENSE INC.GJS2023-04-06
00860007370861Coag-senseCOAGUSENSE INC.GJS2021-09-30
00860007370878Coag-senseCOAGUSENSE INC.GJS2021-09-30
00861900000398Coag-Sense Test Strip Kit, 50 ct.COAGUSENSE INC.GJS2021-09-09
10861900000395Coag-Sense Test Strip Kit, 50 ct.COAGUSENSE INC.GJS2021-09-09
08436540290717microINR ® CHIPS ILINE MICROSYSTEMS SLGJS2021-05-28
08436540290816microINR ® MeterILINE MICROSYSTEMS SLGJS2021-05-28
08436540290700microINR ® CHIPS ILINE MICROSYSTEMS SLGJS2021-05-28