FDA.reportPublic FDA data

Thermo Scientific Pacific Hemostasis®

Primary DI
00845275000863
Brand
Thermo Scientific Pacific Hemostasis®
Company
Fisher Diagnostics
Model
100650
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
GHHFibrin Split Products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHHFibrin Split ProductsHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K852512000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852512000THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KITPacific Hemostasis1985-09-17GHH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275000863PrimaryGS10
00845275005783Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275000863008452750008638452750008630845275000863
00845275005783008452750057838452750057830845275005783

GMDN Terms#

Term, Definition table
TermDefinition
D-dimer IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen, using an agglutination method.

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
4
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
07613336133651Tina-quant D-DimerRoche Diagnostics GmbHGHH2020-12-04
00817089020528DiazymeDIAZYME LABORATORIES, INC.GHH2016-11-03
00817089020535DiazymeDIAZYME LABORATORIES, INC.GHH2016-11-03
00817089020542DiazymeDIAZYME LABORATORIES, INC.GHH2016-11-03
15099590000332AUBeckman Coulter, Inc.GHH2016-09-24
15099590070588AUBeckman Coulter, Inc.GHH2016-09-24
15099590080884AUBeckman Coulter, Inc.GHH2016-09-24
04987595301537PATHFAST D-DimerPHC CORPORATIONGHH2016-09-22
04015630900091Tina-quant D-DimerRoche Diagnostics GmbHGHH2016-09-20
04015630914593Tina-quant D-DimerRoche Diagnostics GmbHGHH2016-09-20
00845275000870Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHH2016-09-16
00845275000887Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHH2016-09-16
00845275000894Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHH2016-09-16
00845275000900Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHH2016-09-16
00816426020368K-ASSAY® D-Dimer ReagentKAMIYA BIOMEDICAL COMPANY, LLCGHH2016-09-16
00816426020665K-ASSAY® D-Dimer CalibratorKAMIYA BIOMEDICAL COMPANY, LLCGHH2016-09-16
03607450004540D-Di Test®DIAGNOSTICA STAGOGHH2016-09-15
15391521420760TriniLIA™ D-Dimer SalineTCOAG IRELAND LIMITEDGHH2016-09-12