FDA.reportPublic FDA data

AutoDELFIA Neonatal Thyroxine (T4) kit

Primary DI
06438147179602
Brand
AutoDELFIA Neonatal Thyroxine (T4) kit
Company
Wallac Oy
Model
B065-01C
Catalog number
B065-01C
Device description
Time-resolved fluoroimmunoassay for the quantitative determination of thyroxine (T4) in dried blood.
Published
2016-02-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CDXRadioimmunoassay, Total Thyroxine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDXRadioimmunoassay, Total ThyroxineClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147179602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147179602064381471796026438147179602

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal thyroxine (neonatal T4) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of neonatal thyroxine (neonatal T4) in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540156544
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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