FDA.reportPublic FDA data

George King Positive Lupus Anticoagulant

Primary DI
00815696020436
Brand
George King Positive Lupus Anticoagulant
Company
GEORGE KING BIO-MEDICAL, INC
Model
5000-0.5
Device description
George King Positive Lupus Anticoagulant is fresh frozen citrated human plasma derived from donors who have been diagnosed with Anti-Phospholipid Antibody Syndrome (APS)
Published
2016-08-20
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
GGCControl, Plasma, Abnormal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGCControl, Plasma, AbnormalHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945856000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945856000POSITIVE LUPUS ANTICOAGULANT PLASMAGeorge King Bio-Medical, Inc.1995-10-05GGC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815696020436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815696020436008156960204368156960204360815696020436

GMDN Terms#

Term, Definition table
TermDefinition
Lupus anticoagulant marker IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00-70˚C or below

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-255-5108plasma@kingbiomed.com

Regulatory Flags#

DUNS number
066761271
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815696021341George King SysCOR-40 Control Kit0065-402023-03-15
00815696021297George King Pooled Normal Plasma0010-60.02022-03-03
00815696021303George King Single Donor Normal Plasma0001-60.02022-03-03
00815696021259George King Pooled Normal Plasma0010-10.02021-01-08
00815696021228George King Single Donor Normal Plasma0001-50.02020-06-26
00815696021235George King SDN Control Kit0075-102020-06-26
00815696021198George King Pooled Normal Plasma0010-500.02019-10-04
00815696021204George King SDN Control Kit0075-202019-11-18
00815696020108George King Pooled Normal Plasma0010-1.02016-07-15
00815696020115George King Pooled Normal Plasma0010-0.52016-08-21
00815696020122George King Pooled Normal Plasma0010-1.52016-08-21
00815696020139George King Pooled Normal Plasma0010-5.02016-08-21
00815696020153George King Single Donor Normal Plasma0001-1.02016-08-21
00815696020160George King Single Donor Normal Plasma0001-bulk2016-08-21
00815696020245George King Pooled Normal Plasma0010-50.02016-08-21
00815696020276George King Pooled Normal Plasma0010-100.02016-08-21
00815696020283George King Pooled Normal Plasma0010-200.02016-08-21
00815696020290George King Pooled Normal Plasma0010-250.02016-08-21
00815696020368George King FACT0020-0.52016-08-17
00815696020375George King FACT0020-1.02016-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198815000107Recombinant Factor VIII Substrate, Porcine SequenceTakeda Pharmaceuticals U.S.A., Inc.GGC2025-08-01
00630414640013LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00630414640099LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00842768019678LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00842768019685LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00630414640167Dade Ci-Trol Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2024-03-25
00842768019470Dade Ci-Trol Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2024-03-25
00630414639703Control Plasma PSiemens Healthcare Diagnostics Products GmbHGGC2024-02-19
00842768018589Control Plasma PSiemens Healthcare Diagnostics Products GmbHGGC2024-02-19
00815696021341George King SysCOR-40 Control KitGEORGE KING BIO-MEDICAL, INCGGC2023-03-15
00815696021143George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INCGGC2020-03-27
00815696021150George King Factor XIII Deficient PlasmaGEORGE KING BIO-MEDICAL, INCGGC2020-03-27
00817869020243Animal Plasma Control Level IIANALYTICAL CONTROL SYSTEMS INCGGC2019-01-31
00815696021112George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INCGGC2018-06-22
00815696021051George King AbCOR Convenience KitGEORGE KING BIO-MEDICAL, INCGGC2017-04-17
00815696021068George King AbCOR Convenience KitGEORGE KING BIO-MEDICAL, INCGGC2017-04-17
00630414023502LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2017-02-15
00630414023519LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2017-02-15
10859394006061PlasmaCon NR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006078PlasmaCon L1R 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006085PlasmaCon L2R 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006108LupoTek Detectin VLR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006115LupoTek Correctin VLR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006122PlasmaCon LAR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006139PlasmaCon LAR 2 DIAGNOSTICS, INC.GGC2016-11-15
00842768004056Dade® Ci-Trol® Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768006838Berichrom® Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768006852Berichrom® Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768008351LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768008368LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2016-09-24