FDA.reportPublic FDA data

PATHFAST D-Dimer

Primary DI
04987595301537
Brand
PATHFAST D-Dimer
Company
PHC CORPORATION
Model
N/A
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K072288000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072288000PATHFAST D-DIMERMitsubishi Kagaku Iatron2009-05-06GHH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987595301537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987595301537049875953015374987595301537

GMDN Terms#

Term, Definition table
TermDefinition
D-dimer IVD, kit, chemiluminescent immunoassayA 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 a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
716055632
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987595300011PATHFAST Sample Diluent 1N/A2025-04-18
04987595300028PATHFAST Sample Diluent 2N/A2025-04-18
04987595300646PATHFASTN/A3006462023-06-12
04987595301131PATHFAST cTnI-IIN/A2016-09-22
04987595301230PATHFAST Myo-IIN/A2016-09-22
04987595301339PATHFAST CK-MB-IIN/A2016-09-22
04987595301636PATHFAST NTproBNPN/A2016-09-22
04987595301742PATHFAST hsCRPN/A2016-09-22
04987595301803PATHFAST hs-cTnI-IIN/A3018032024-05-01
04987905300236PHCbiMCO-170MG-PA2018-04-25
04987905300199PHCbiMDF-U334-PA2018-04-25
04987905300205PHCbiMDF-U5312-PA2018-04-25
04987905300212PHCbiMCO-5M-PA2018-04-25
04987905300045PanasonicMCO-170AICUV-PA2016-09-24
04987905300069PanasonicMCO-19M-PA2016-09-24
04987905300076PanasonicMCO-19MUV-PA2016-09-24
04987905300090PanasonicMCO-230AICUV-PA2016-09-24
04987905300113PanasonicMCO-5M-PA2016-09-24
04987905300120PanasonicMCO-170M-PA2016-09-24
04987905300229PHCbiMCO-170M-PA2018-04-25

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
04015630900091Tina-quant D-DimerRoche Diagnostics GmbHGHH2016-09-20
04015630914593Tina-quant D-DimerRoche Diagnostics GmbHGHH2016-09-20
00845275000863Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHH2016-09-16
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