Human Microalbumin Kit for use on SPAPLUS

Primary DI
05051700017923
Brand
Human Microalbumin Kit for use on SPAPLUS
Company
THE BINDING SITE GROUP LIMITED
Model
NK032.U.S.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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DCFAlbumin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DCFAlbumin, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143118000Human Microalbumin kit for use on SPAPLUSThe Binding Site Group , Ltd.2015-05-26DCF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051700017923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051700017923050517000179235051700017923

GMDN Terms#

Term, Definition table
TermDefinition
Microalbumin IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of microalbumin in a clinical specimen, using a nephelometry/turbidimetry method.

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
Kit
true
Lot or batch
true
Expiration date on label
true

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