FDA.report

PreciControl Growth

Primary DI
07613336129494
Brand
PreciControl Growth
Company
Roche Diagnostics GmbH
Model
07476108190
Catalog number
07476108190
Published
2017-09-06
Public version status
Update
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
07613336129494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613336129494076133361294947613336129494

GMDN Terms

TermDefinition
Insulin-like growth factor I (IGF1) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of insulin-like growth factor I (IGF1), also referred to as somatomedin C, in a clinical specimen.

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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