FDA.report

Elecsys FT4 IV

Primary DI
07613336172780
Brand
Elecsys FT4 IV
Company
Roche Diagnostics GmbH
Model
09043284190
Catalog number
09043284190
Published
2023-05-02
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
CECRADIOIMMUNOASSAY, FREE THYROXINE

Product Code Classifications

CodeDeviceSpecialtyClass
CECRadioimmunoassay, Free ThyroxineClinical Chemistry2

Premarket Submissions

SubmissionSupplement
K220456000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K220456000Elecsys FT4 IVRoche Diagnostics2023-04-07CEC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613336172780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613336172780076133361727807613336172780

GMDN Terms

TermDefinition
Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of free thyroxine (FT4) 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
false
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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