FDA.reportPublic FDA data

Accutrend Cholesterol Controls

Primary DI
00365702250109
Brand
Accutrend Cholesterol Controls
Company
Roche Diagnostics GmbH
Model
5219957001
Catalog number
5219957001
Published
2021-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JJXSingle (specified) analyte controls (assayed and unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00365702250109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00365702250109003657022501093657022501090365702250109

GMDN Terms#

Term, Definition table
TermDefinition
Total cholesterol lipid IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total cholesterol lipid 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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