FDA.reportPublic FDA data

Coag-Sense Test Strip Kit, 50 ct.

Primary DI
00861900000398
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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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, rapid clotting, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative determination 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 is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
007943352
Device count
50
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
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
10861900000395Coag-Sense Test Strip Kit, 50 ct.10021803P56-502021-09-09

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00850053916182IDG/SanzayIDG/SANZAY CorporationGJS2024-01-12
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00860007370861Coag-senseCOAGUSENSE INC.GJS2021-09-30
00860007370878Coag-senseCOAGUSENSE INC.GJS2021-09-30
10861900000395Coag-Sense Test Strip Kit, 50 ct.COAGUSENSE INC.GJS2021-09-09
08436540290717microINR ® CHIPS ILINE MICROSYSTEMS SLGJS2021-05-28
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