FDA.reportPublic FDA data

Thermo Scientific Pacific Hemostasis®

Primary DI
00845275000757
Brand
Thermo Scientific Pacific Hemostasis®
Company
Fisher Diagnostics
Model
100258
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
GHMTest, Sickle Cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHMTest, Sickle CellHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K854079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K854079000THROMBO SCREEN SICKLE CELL ASSAY SETPacific Hemostasis1985-10-31GHM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275000757PrimaryGS10
00845275005516Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275000757008452750007578452750007570845275000757
00845275005516008452750055168452750055160845275005516

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin S (HbS) IVD, kit, electrophoresisA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype S (HbS), also known as sickle cell haemoglobin, in a clinical specimen using an electrophoresis method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-528-0494xx@xx.xx

Regulatory Flags#

DUNS number
183998769
Device count
8
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
00860003629901Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00860003629918Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00860003629925Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00860003629932Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00860003629949Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00630414976341Dade® Sickle-Sol TestSiemens Healthcare Diagnostics Products GmbHGHM2016-09-24
00630414976365Dade® Sickle-Sol TestSiemens Healthcare Diagnostics Products GmbHGHM2016-09-24
00844509000884Sickle-ChexSTRECK, INC.GHM2016-09-19
00844509000891Sickle-ChexSTRECK, INC.GHM2016-09-19
00844509002024SICKLEDEXSTRECK, INC.GHM2016-09-19
00844509002031SICKLEDEXSTRECK, INC.GHM2016-09-19
00844509002048SICKLEDEXSTRECK, INC.GHM2016-09-19
00845275000740Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHM2016-09-16
00845275000733Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHM2016-07-19
00816057020003ASI Sickle Cell TestARLINGTON SCIENTIFIC, INC.GHM2016-07-08
00816057020010ASI Sickle Cell TestARLINGTON SCIENTIFIC, INC.GHM2016-07-08
00816057020027ASI Sickle Cell TestARLINGTON SCIENTIFIC, INC.GHM2016-07-08
00816057020034ASI Sickle Cell TestARLINGTON SCIENTIFIC, INC.GHM2016-07-08