FDA.report

PreciControl ThyroAB

Primary DI
04015630923946
Brand
PreciControl ThyroAB
Company
Roche Diagnostics GmbH
Model
05042666191
Catalog number
05042666191
Published
2020-04-15
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
true

Related Records

Product Codes

CodeName
JJYMulti-analyte controls, all kinds (assayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04015630923946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04015630923946040156309239464015630923946

GMDN Terms

TermDefinition
Multiple thyroid marker IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple thyroid markers associated with thyroid disease in a clinical specimen. Analytes detected may include, but are not limited to free triiodothyronine (FT3), free thyroxine (FT3), thyroid stimulating hormone (TSH) and/or thyroid peroxidase (TPO).

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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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