FDA.reportPublic FDA data

REAADS Coagulation Control 1

Primary DI
00855360006243
Brand
REAADS Coagulation Control 1
Company
CORGENIX MEDICAL CORPORATION
Model
701-001
Catalog number
701-001
Device description
REAADS Coagulation Control 1 (CC-1) is an assayed control plasma in coagulation studies for In Vitro Diagnostic Use.PRINCIPLE OF THE PROCEDURECoagulation Control 1 is tested in the same manner as citrated patient plasma samples to assess the performance of each assay run, for the parameters. Testing variables in each laboratory, including equipment, reagents, and technique may influence control recovery. Although an expected range is provided for each parameter, laboratories should establish their own expected range for their particular instrument-reagent system. Refer to Package Insert.
Published
2016-07-14
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
GIZPlasma, Control, Normal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIZPlasma, Control, NormalHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941737000SPECIALTY ASSAYED CONTROL-1Helena Laboratories1994-10-07GIZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855360006243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855360006243008553600062438553600062430855360006243

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-729-5661technicalsupport@corgenix.com

Regulatory Flags#

DUNS number
619834542
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855360006250REAADS Coagulation Control 2702-001702-0012016-07-14
00867444000207BGM GALECTIN-30012016-07-26
00855360006007REAADS Protein S Antigen Test kit036-001036-0012016-07-14
00855360006014REAADS Monoclonal Free Protein S Antigen051-001051-0012016-07-14
00855360006021REAADS Protein C Test Kit035-001035-0012016-05-26
00855360006038REAADS von Willebrand Factor Antigen Test Kit034-001034-0012016-07-14
00855360006069Corgenix Anti-Cardiolipin IgG Semi-Quantitative Test Kit (192 Well)13525135252016-07-14
00855360006076Corgenix Anti-Cardiolipin IgM Semi-Quantitative Test Kit (192 Well)13529135292016-07-14
00855360006083Corgenix Anti-Cardiolipin IgA Semi-Quantitative Test Kit (192 Well)13530135302016-07-14
00855360006113Corgenix Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit (192 Well)13534135342016-07-14
00855360006120Corgenix Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (192 Well)13536135362016-07-14
00855360006137Corgenix Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit (192 Well)13535135352016-07-14
00855360006175Corgenix Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (192 Well)13370133702016-07-14
00855360006182Corgenix Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (192 Well)13371133712016-07-14
00855360006199Corgenix Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (192 Well)13372133722016-07-14
00855360006236Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody)11854118542016-08-08
00855360006267REAADS von Willebrand Factor Activity Test Kit10826108262016-07-14
0085536000627411dhTxB2 Test Kit (11-Dehydro Thromboxane B2)12136121362016-08-08
00855360006045REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit (96 Well)023-001023-0012016-07-14
00855360006052REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit (96-Well)026-001026-0012016-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10859394006061PlasmaCon NR 2 DIAGNOSTICS, INC.GIZ2016-11-15
10859394006078PlasmaCon L1R 2 DIAGNOSTICS, INC.GIZ2016-11-15
10859394006085PlasmaCon L2R 2 DIAGNOSTICS, INC.GIZ2016-11-15
00842768006821Berichrom® Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGIZ2016-09-24
00842768006876Berichrom® Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGIZ2016-09-24
00843876000053CRYOcheck™ Reference Control NormalPrecision Biologic IncGIZ2016-09-23
00843876000060CRYOcheck™ Reference Control NormalPrecision Biologic IncGIZ2016-09-23
00850201006147LAtrol NORMAL CONTROL PLASMABiomedica ADI Inc.GIZ2016-09-20
00845275000559Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIZ2016-09-16
13607450006756STA® - UnicalibratorDIAGNOSTICA STAGOGIZ2016-09-15
15391521420777TriniCHECK™ D-Dimer 1TCOAG IRELAND LIMITEDGIZ2016-09-12
M52553010Coagulation S.A.C.-1 (Specialty Assay Control)HELENA LABORATORIES CORPORATIONGIZ2016-09-07