FDA.reportPublic FDA data

Coag-Sense Test Strip Kit, 50 ct.

Primary DI
10861900000395
Brand
Coag-Sense Test Strip Kit, 50 ct.
Company
COAGUSENSE INC.
Model
100218
Catalog number
03P56-50
Device description
Test Strip Kit, 50 ct.
Published
2021-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861900000336PreviousGS10
00861900000398PrimaryGS10
10861900000395Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861900000336008619000003368619000003360861900000336
00861900000398008619000003988619000003980861900000398
1086190000039510861900000395

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 Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-903-0890techsupport@coagusense.com

Regulatory Flags#

DUNS number
007943352
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007370809Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing3005503005502026-05-12
00850040656022Assure PT Care PT/INR Monitoring System 3502223502222023-04-06
00860007370861Coag-sense03F73-0306F73-032021-09-30
00860007370878Coag-sense03F73-0506F73-052021-09-30
00850040656039Assure PT Care Test Strip Kit3502183502182023-04-06
00861900000398Coag-Sense Test Strip Kit, 50 ct.10021803P56-502021-09-09
00861900000350Coag-Sense PT/INR Meter20010703P73-012019-04-03
00861900000374Coag-Sense PT/INR Professional System20022203P70-022019-04-03
00861900000381Coag-Sense PT/INR Patient Self-Test System20022103P70-012019-04-03
00861900000305Coag-Sense10010703P63-012018-09-23
00861900000312Coag-sense10022203P60-012018-09-23
00861900000329Coag-sense10022103P50-012018-09-23
00861900000336Coag-sense10021803P56-502018-09-23
00861900000343Coag-sense10025003P69-102018-09-23

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Primary DI, Brand, Company table
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09360136000093Xprecia Prime™ PT/INR Test StripsUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
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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
08436540290717microINR ® CHIPS ILINE MICROSYSTEMS SLGJS2021-05-28
08436540290816microINR ® MeterILINE MICROSYSTEMS SLGJS2021-05-28
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