FDA.report

CalSet FT4 IV

Primary DI
07613336175088
Brand
CalSet FT4 IV
Company
Roche Diagnostics GmbH
Model
09043292160
Catalog number
09043292160
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
JISCalibrator, primary

Product Code Classifications

CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613336175088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613336175088076133361750887613336175088

GMDN Terms

TermDefinition
Free thyroxine (FT4) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of free thyroxine (FT4) in a clinical specimen.

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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