FDA.reportPublic FDA data

Complement C2 Calibrator Set

Primary DI
05051700020381
Brand
Complement C2 Calibrator Set
Company
THE BINDING SITE GROUP LIMITED
Model
NC022.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
JISCalibrator, Primary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051700020381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051700020381050517000203815051700020381

GMDN Terms#

Term, Definition table
TermDefinition
Complement component C2 IVD, calibratorA material which is used to establish known points of reference for an assay intended to be 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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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
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05051700021036Optilite® IgG3 Kit (x10)LK008.10.OPT.A2023-09-27
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Primary DI, Brand, Company table
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