FDA.report

Hevylite IgG Lambda Kit for Siemens BNII

Primary DI
05051700016988
Brand
Hevylite IgG Lambda Kit for Siemens BNII
Company
THE BINDING SITE GROUP LIMITED
Model
NK622.T.A
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

Related Records

Contact Domains

Product Codes

CodeName
PCOImmunoglobulin G Lambda Heavy And Light Chain Combined

Product Code Classifications

CodeDeviceSpecialtyClass
PCOImmunoglobulin G Lambda Heavy And Light Chain CombinedImmunology2

Premarket Submissions

SubmissionSupplement
K132555000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K132555000HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KITThe Binding Site2013-12-20PCN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05051700016988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05051700016988050517000169885051700016988

GMDN Terms

TermDefinition
Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin G (IgG total) in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05051700020121Optilite Hevylite IgG Lambda KitTHE BINDING SITE GROUP LIMITEDPCO2018-04-12
05051700019385Hevylite Human IgG Lambda Kit for use on the SPAPLTHE BINDING SITE GROUP LIMITEDPCO2017-07-25