FDA.reportPublic FDA data

Elecsys FT4 II Assay

Primary DI
04015630934232
Brand
Elecsys FT4 II Assay
Company
Roche Diagnostics GmbH
Model
6437281160
Catalog number
6437281160
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CECRADIOIMMUNOASSAY, FREE THYROXINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CECRadioimmunoassay, Free ThyroxineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131244000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131244000ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSETRoche Diagnostics2014-01-27CEC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630934232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630934232040156309342324015630934232

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

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

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590780982Access Free T4Beckman Coulter, Inc.CEC2024-03-12
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00894175000923AccuDiag ™Diagnostic Automation, Inc.CEC2023-06-14
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07613336172780Elecsys FT4 IVRoche Diagnostics GmbHCEC2023-05-02
06947145577971MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.CEC2022-08-02
06947145577988MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.CEC2022-08-02
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08809317540382FREND Free T4NanoEnTek, Inc.CEC2018-05-04
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