FDA.reportPublic FDA data

Human IgM Control Pack for use on the SPAPLUS®

Primary DI
05051700018883
Brand
Human IgM Control Pack for use on the SPAPLUS®
Company
THE BINDING SITE GROUP LIMITED
Model
NQ012.S
Published
2017-06-05
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
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05051700018883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05051700018883050517000188835051700018883

GMDN Terms

TermDefinition
Total immunoglobulin M (IgM total) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total immunoglobulin M (IgM total) in a clinical specimen.

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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