FDA.reportPublic FDA data

FSH CalSet II

Primary DI
07613336170397
Brand
FSH CalSet II
Company
Roche Diagnostics GmbH
Model
08932417190
Catalog number
08932417190
Published
2021-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JITCalibrator, secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336170397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336170397076133361703977613336170397

GMDN Terms#

Term, Definition table
TermDefinition
Follicle stimulating hormone (FSH) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of follicle stimulating hormone (FSH) in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
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