FDA.report

Elecsys T4

Primary DI
07613336171660
Brand
Elecsys T4
Company
Roche Diagnostics GmbH
Model
09007741190
Catalog number
09007741190
Published
2021-08-13
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

Related Records

Product Codes

CodeName
CDXRadioimmunoassay, total thyroxine

Product Code Classifications

CodeDeviceSpecialtyClass
CDXRadioimmunoassay, Total ThyroxineClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613336171660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613336171660076133361716607613336171660

GMDN Terms

TermDefinition
Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of total thyroxine (TT4) in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315028860
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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