FDA.report

sLDL CONTROL - LEVEL 1 (sLDL CONTROL 1)

Primary DI
05055273209075
Brand
sLDL CONTROL - LEVEL 1 (sLDL CONTROL 1)
Company
RANDOX LABORATORIES LIMITED
Model
LE5013
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055273209075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055273209075050552732090755055273209075

GMDN Terms

TermDefinition
Dense low density lipoprotein (DLDL) cholesterol IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of dense low density lipoprotein (DLDL) cholesterol lipid in a clinical specimen.

Sterilization Methods

Method

Regulatory Flags

DUNS number
227530649
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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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