FDA.reportPublic FDA data

Human Complement C4 ‘NL’ BINDARID™ Radial Immunodi

Primary DI
05051700010559
Brand
Human Complement C4 ‘NL’ BINDARID™ Radial Immunodi
Company
THE BINDING SITE GROUP LIMITED
Model
RN025.3
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CZWComplement C3, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CZWComplement C3, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902382000C3C AND C4 RID KITSThe Binding Site, Ltd.1990-09-07CZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051700010559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051700010559050517000105595051700010559

GMDN Terms#

Term, Definition table
TermDefinition
Complement components C4/C4c IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of complement cascade components C4 and/or C4c 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
+4401214569500info@bindingsite.co.uk

Regulatory Flags#

DUNS number
347045614
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051700021104Freelite® Human Kappa Free Kit for use on the Roche cobas® c SystemsLK016.CB.A2026-02-02
05051700021111Freelite® Human Lambda Free Kit for use on the Roche cobas® c SystemsLK018.CB.A2026-02-02
05051700020602EXENT® Immunoglobulin Isotypes (GAM) Control PackMSQ801.M2025-11-27
05051700020640EXENT® Diluent 1IK8762025-11-27
05051700020657EXENT® Elution buffer 1 IK8772025-11-27
05051700020664EXENT® HCCA MALDI Matrix PackIK8202025-11-27
05051700020671EXENT® Mass calibration standard 1 MSS801.M2025-11-27
05051700020688EXENT® Disposable MALDI plate pack IK8192025-11-27
05051700020695EXENT® Wash solution 1 IK8222025-11-27
05051700020886EXENT® AnalyserIE800.A2025-11-27
05051700021050Immunoglobulin Isotypes (GAM) for the EXENT AnalyserMSR801.M.A2025-11-27
05051700021098Optilite® CH50 ReagentNK095.OPT.A2024-11-20
05051700019392Optilite® Low Level Total Protein ControlsNQ061.L.OPT2024-10-30
05051700020534Optilite® Low Level Total Protein CalibratorNC061.L.OPT2024-10-30
05051700020558Optilite® Low Level Total Protein ReagentNK061.L.OPT.A2024-10-30
05051700021036Optilite® IgG3 Kit (x10)LK008.10.OPT.A2023-09-27
05051700021043Optilite® IgG4 Kit (x10)LK009.10.OPT.A2023-09-27
05051700016803Freelite® Kappa AMR Check Fluid SDBP538.SD2023-08-09
05051700016810Freelite® Lambda AMR Check Fluid SDBP539.SD2023-08-09
05051700002059Freelite® Panel Sample SetBP2282023-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740170172AlinityABBOTT IRELANDCZW2021-05-13
00380740170189ARCHITECTABBOTT IRELANDCZW2021-03-26
00380740175153ARCHITECTAbbott GmbHCZW2020-11-06
07613336133590Tina-quant Complement C3c Ver.2Roche Diagnostics GmbHCZW2020-03-05
00380740150662AlinityAbbott GmbH & Co. KGCZW2019-06-27
00630414595665Atellica CH C3Siemens Healthcare Diagnostics Inc.CZW2017-12-27
15099590010560AUBeckman Coulter, Inc.CZW2016-09-24
B1761050Antiserum to Human C-3 (b1c/b1a)KENT LABORATORIES INCCZW2016-09-24
B1761052Anti Human C-3 (b1c/b1a) FITCKENT LABORATORIES INCCZW2016-09-24
B1761190Antiserum to Human C-3 (b1c)KENT LABORATORIES INCCZW2016-09-24
05051700010542Human Complement C3 ‘NL’ BINDARID™ Radial ImmunodiTHE BINDING SITE GROUP LIMITEDCZW2016-09-24
05051700015578Human C3c Kit for use on the SPAplusTHE BINDING SITE GROUP LIMITEDCZW2016-09-24
05051700017596Optilite C3c KitTHE BINDING SITE GROUP LIMITEDCZW2016-09-24
00842768005220Dimension® Flex® reagent cartridge C3Siemens Healthcare Diagnostics Inc.CZW2016-09-24
00842768006050Dimension Vista® C3 Complement Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHCZW2016-09-24
00842768009716N Antiserum to Human C3cSiemens Healthcare Diagnostics Products GmbHCZW2016-09-24
00842768009723N Antiserum to Human C3cSiemens Healthcare Diagnostics Products GmbHCZW2016-09-24
00630414517735ADVIA® Chemistry C3 Complement C3 ReagentsSiemens Healthcare Diagnostics Inc.CZW2016-09-24
00813545023829Scanlisa C3d Elisa 96 Test SCIMEDX CORPORATIONCZW2016-09-20
00813545023836C3d Plates & Calibrator Sets SCIMEDX CORPORATIONCZW2016-09-20
05055273201611C3RANDOX LABORATORIES LIMITEDCZW2016-09-16
05700572002482Poly Rb A-Hu C3c Complement/FITCDako Denmark ApSCZW2016-09-16
00816426020078K-ASSAY® Complement C3 ReagentKAMIYA BIOMEDICAL COMPANY, LLCCZW2016-09-16
00817302020922CAROLINA LIQUID CHEMISTRIES CORP.® C3 Complement C3 CC634CAROLINA LIQUID CHEMISTRIES CORPORATIONCZW2016-09-01
15099590229733SynchronBeckman Coulter, Inc.CZW2016-08-24
15099590230487IMMAGEBeckman Coulter, Inc.CZW2016-08-24
10758750006847VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CZW2016-08-23
00380740019730ARCHITECTABBOTT LABORATORIESCZW2016-06-06