FDA.reportPublic FDA data

Elecsys T3 CalSet

Primary DI
04015630899920
Brand
Elecsys T3 CalSet
Company
Roche Diagnostics GmbH
Model
11731548122
Catalog number
11731548122
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
JISCALIBRATOR, PRIMARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962508000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962508000ELECSYS T3Boehringer Mannheim Corp.1996-08-15CDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630899920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630899920040156308999204015630899920

GMDN Terms#

Term, Definition table
TermDefinition
Total triiodothyronine (TT3) 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 triiodothyronine (TT3) 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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07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
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