FDA.reportPublic FDA data

Coatest APC Resistance V

Primary DI
08426950060017
Brand
Coatest APC Resistance V
Company
INSTRUMENTATION LABORATORY COMPANY
Model
82 3120 63
Catalog number
82 3120 63
Device description
Coatest APC Resistance V
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GGWTEST, TIME, PARTIAL THROMBOPLASTIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGWTest, Time, Partial ThromboplastinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963111000COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V SChromogenix AB1996-12-23GGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950060017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950060017084269500600178426950060017

GMDN Terms#

Term, Definition table
TermDefinition
Activated protein C resistant factor V (factor V Leiden) IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of factor V Leiden, a clotting protein resistant to cleavage by activated protein C, in a clinical specimen using a clotting method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The sealed reagents are stable at 2-8°C until the expiry date printed on the label. Avoid contamination of the reagents by microorganisms.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-678-0710techsupport@werfen.com
1-800-678-0710techsupport.na@werfen.com

Regulatory Flags#

DUNS number
557223252
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
08426950071068HemosIL Normal Control ASSAYED00020003110000200031102016-09-23
08426950088646GEM Check Coag Control-Abnormal for ACT-LR06260060200062600602002016-09-23
08426950088653GEM Check Coag Control-Abnormal for ACT06260060300062600603002016-09-23
08426950452683GEM Check Coag Control-Normal for Citrate PT06260061100062600611002016-09-23
08426950452713GEM Check Coag Control-Abnormal for Citrate PT06260061400062600614002016-09-23
08426950452744GEM Check Coag Control-Normal for ACT06260060500062600605002016-09-23
08426950452751GEM Check Coag Control-Normal for ACT-LR06260060600062600606002016-09-23
08426950573401HemosIL Routine Control Level 300020005800000200058002016-09-23
08426950660668HemosIL Abnormal Control 200020014000000200140002016-09-23
08426950078982HemosIL Low Abnormal Control ASSAYED00020003210000200032102016-09-23
08426950078999HemosIL High Abnormal Control ASSAYED00020003310000200033102016-09-23
08426950087595HemosIL Calibration Plasma00020003700000200037002016-09-23
08426950088639GEM Check Coag Control-Abnormal for APTT06260060100062600601002016-09-23
08426950088912Coatest APCR Control Plasma Level 182 2650 6382 2650 632016-09-23
08426950088929Coatest APCR Control Plasma Level 282 2668 6382 2668 632016-09-23
08426950442189HemosIL Special Test Control Level 200020012000000200120002016-09-23
08426950452690GEM Check Coag Control-Normal for APTT06260061600062600616002016-09-23
08426950452706GEM Check Coag Control-Abnormal for PT06260061700062600617002016-09-23
08426950452737GEM Check Coag Control-Normal for PT06260060400062600604002016-09-23
08426950453062HemosIL Special Test Control Level 100020011000000200110002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414640242Dade Actin FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00630414640327Dade Actin FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00630414640341Dade Actin FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00630414640358Dade Actin FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00630414639758Factor V LeidenSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00842768019562Dade Actin FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
00842768019555Dade Actin FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2024-03-25
13607450012627PTT-LADIAGNOSTICA STAGOGGW2021-03-23
03607450012620PTT-LADIAGNOSTICA STAGOGGW2021-03-23
07640175460013PefakitPentapharm AGGGW2017-01-25
10859394006016Phospholin ES w/ Calcium ChlorideR 2 DIAGNOSTICS, INC.GGW2016-11-15
10859394006146LupoTek KCTR 2 DIAGNOSTICS, INC.GGW2016-11-15
10859394006238Phospholin ES w/CalciumR 2 DIAGNOSTICS, INC.GGW2016-11-15
00842768003844Dade® Actin® FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
00842768003868Dade® Actin® FS Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
00842768003875Dade® Actin® FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
00842768003882Dade® Actin® FSL Activated PTT ReagentSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
00842768033520Factor V LeidenSiemens Healthcare Diagnostics Products GmbHGGW2016-09-24
08426950076100Coatest APC Resistance V-SINSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950060147Coatest APC ResistanceINSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950062424HemosIL Factor V Leiden (APC Resistance V)INSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950087656HemosIL Factor V Reagent Plasma (for APC R V)INSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950088912Coatest APCR Control Plasma Level 1INSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
08426950088929Coatest APCR Control Plasma Level 2INSTRUMENTATION LABORATORY COMPANYGGW2016-09-23
00843876000435CRYOcheck™ Platelet LysatePrecision Biologic IncGGW2016-09-23
00850201006192ACTICLOT Protein C Resistance KitBiomedica ADI Inc.GGW2016-09-20
03607450005974STA® - C.K. Prest® 5DIAGNOSTICA STAGOGGW2016-09-15
13607450005957STA® - PTT A 5DIAGNOSTICA STAGOGGW2016-09-15
13607450005995PTT-LADIAGNOSTICA STAGOGGW2016-09-15
M52551870AB-TROL 2 Coagulation ControlHELENA LABORATORIES CORPORATIONGGW2016-09-07