FDA.reportPublic FDA data

Anti-Human Complement C2 Latex Reagent

Primary DI
05051700020367
Brand
Anti-Human Complement C2 Latex Reagent
Company
THE BINDING SITE GROUP LIMITED
Model
LK022.A
Published
2019-01-30
Public version status
New
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
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051700020367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051700020367050517000203675051700020367

GMDN Terms#

Term, Definition table
TermDefinition
Complement component C2 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 complement cascade component C2 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
+441214569500info@bindingsite.co.uk

Regulatory Flags#

DUNS number
347045614
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

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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
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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
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