FDA.reportPublic FDA data

QuikCoag PT-HS

Primary DI
10627944000032
Brand
QuikCoag PT-HS
Company
Biomedica Diagnostics Inc
Model
10 mL
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K020840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020840000VITAL SCIENTIFIC PT WITH CALCIUMVital Scientific N.V.2002-05-15GJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10627944000032PackageGS110In Commercial Distribution
00627944000035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062794400003210627944000032
00627944000035006279440000356279440000350627944000035

GMDN Terms#

Term, Definition table
TermDefinition
Prothrombin time (PT) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR).

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
200152713
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627944000035QuikCoag PT-HS10 mL2016-09-22
00627944000066QuikCoag Control Level 1 Normal1 mL2016-09-22
00627944000073QuikCoag Control Level 2 Low Abnormal1 mL2016-09-22
00627944000080QuikCoag Control Level 3 High Abnormal1 mL2016-09-22
00627944000097QuikCoag Calcium Chloride 0.02M4 mL2016-09-22
00627944000103QuikCoag Calcium Choride 0.02M10 mL2016-09-22
00627944000011QuikCoag PT-HS2 mL2016-09-22
00627944000028QuikCoag PT-HS4 mL2016-09-22
00627944000042QuikCoag APTT-EA4 mL2016-09-22
00627944000059QuikCoag APTT-EA10 mL2016-09-22
10627944000063QuikCoag Control Level 1 Normal1 mL2016-09-22
10627944000070QuikCoag Control Level 2 Low Abnormal1 mL2016-09-22
10627944000087QuikCoag Control Level 3 High Abnormal1 mL2016-09-22
10627944000094QuikCoag Calcium Chloride 0.02M4 mL2016-09-22
10627944000100QuikCoag Calcium Choride 0.02M10 mL2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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