FDA.reportPublic FDA data

HEMOCLOT Quanti. V-L

Primary DI
03663537017964
Brand
HEMOCLOT Quanti. V-L
Company
HYPHEN BIOMED
Model
CK065K
Catalog number
CK065K
Published
2016-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K083729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083729000HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHENAniara Diagnostica, LLC2009-05-08GGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663537017964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663537017964036635370179643663537017964

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
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
503499167
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03663537008306BIOPHEN NORMAL CONTROL PLASMA2232012232012016-08-25
03663537008313BIOPHEN ABNORMAL CONTROL PLASMA2233012233012016-08-25
03663537008221BIOPHEN Protein C 2.52212022212022016-08-25
03663537008047Imidazole bufferAR021AAR021A2020-06-30
03663537008450Calcium chloride 0.025M (M/40)AR001AAR001A2020-06-30
03663537008474Calcium chloride 0.25M (M/4)AR002AAR002A2020-06-30
03663537008481Calcium chloride 0.25M (M/4)AR002KAR002K2020-06-30
03663537084805Imidazole bufferAR021B2020-10-28
03663537084829Imidazole bufferAR021M2020-10-28
03663537084843Imidazole bufferAR021N2020-10-28
03663537010439Imidazole bufferAR021KAR021K2020-06-30
03663537010446Imidazole bufferAR021LAR021L2020-06-30
03663537084768Calcium chloride 0.025M (M/40)AR001BAR001B2020-11-16
03663537084782Calcium chloride 0.025M (M/40)AR001LAR001L2020-11-16
03663537008320BIOPHEN™ V-L Control Plasma 2234052234052016-08-25
03663537019074BIOPHEN™ V-L Plasma Calibrator2224012224012016-08-25
03663537008467Calcium chloride 0.025M (M/40)AR001K2020-06-30
03663537007989BIOPHEN LMWH Control C32238012238012016-08-25
03663537007996BIOPHEN UFH CONTROL C22239012239012016-08-25
03663537008184BIOPHEN HEPARIN 32210032210032016-08-25

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
08426950060017Coatest APC Resistance VINSTRUMENTATION 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