FDA.reportPublic FDA data

Phospholin ES w/ Calcium Chloride

Primary DI
10859394006016
Brand
Phospholin ES w/ Calcium Chloride
Company
R 2 DIAGNOSTICS, INC.
Model
21-410
Catalog number
21-410
Device description
APTT reagent 5 x 10 ml with 5 Calcium Chloride
Published
2016-11-15
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
K033471000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033471000PHOSPHOLIN ES AND CALCIUM CHLORIDER2 Diagnostics, Inc.2004-02-04GGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859394006016PrimaryGS10
00859394006019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085939400601610859394006016
00859394006019008593940060198593940060190859394006019

GMDN Terms#

Term, Definition table
TermDefinition
Activated partial thromboplastin time (APTT) 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 activated partial thromboplastin time (APTT) of a clinical specimen.

Regulatory Flags#

DUNS number
956610125
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10859394006061PlasmaCon N30-20130-2012016-11-15
10859394006078PlasmaCon L131-20131-2012016-11-15
10859394006085PlasmaCon L232-20132-2012016-11-15
10859394006122PlasmaCon LA150-200150-2002016-11-15
10859394006139PlasmaCon LA150-201150-2012016-11-15
10859394006023Phosphoplastin RL11-30511-3052016-11-15
10859394006030Phosphoplastin RL11-31011-3102016-11-15
10859394006054T-tek50-20150-2012016-11-15
10859394006108LupoTek Detectin VL85-20285-2022016-11-15
10859394006115LupoTek Correctin VL86-20186-2012016-11-15
10859394006146LupoTek KCT87-30587-3052016-11-15
10859394006153NoFact VIII68-20168-2012016-11-15
10859394006160NoFact IX69-20169-2012016-11-15
10859394006191FIB Calibrator71-20171-2012016-11-15
10859394006238Phospholin ES w/Calcium21-40521-4052016-11-15
00859394006040Fibrotek70-41070-4102016-11-15
00859394006095ThromboTek PSe90-48090-4802016-11-15
10859394006177PlasmaRef ARN33-20133-2012016-11-15
10859394006184PlasmaRef ARL-235-20135-2012016-11-15

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
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
M52551870AB-TROL 2 Coagulation ControlHELENA LABORATORIES CORPORATIONGGW2016-09-07