FDA.reportPublic FDA data

Elecsys CalSet T4

Primary DI
04015630912711
Brand
Elecsys CalSet T4
Company
Roche Diagnostics GmbH
Model
12017717122
Catalog number
12017717122
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
CDXRadioimmunoassay, total thyroxine

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961490000ELECSYS T4 ASSAYBoehringer Mannheim Corp.1996-06-13CDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630912711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630912711040156309127114015630912711

GMDN Terms#

Term, Definition table
TermDefinition
Total thyroxine (TT4) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of total thyroxine (TT4) in a clinical specimen.

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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20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
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07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026484QMedix™Diagnostic Automation, Inc.CDX2024-01-31
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00840239045683T-4 Total ELISADRG International IncCDX2023-08-25
06925912718512iFlash-T4Shenzhen YHLO Biotech Co., Ltd.CDX2022-10-26
07613336171660Elecsys T4Roche Diagnostics GmbHCDX2021-08-13
07613336171677Elecsys T4Roche Diagnostics GmbHCDX2021-08-13
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00816870023106Monobind AccuLite T4 CLIA Kit - 192 WellsMONOBIND, INC.CDX2019-02-11
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