FDA.report

ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE)

Primary DI
05055273216486
Brand
ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE)
Company
RANDOX LABORATORIES LIMITED
Model
LV10366
Catalog number
LV10366
Device description
Enzymes Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for ALT, AST, Alkaline Phosphatase (ALP), Total Amylase, Pancreatic Amylase, CK, CKMB, Gamma GT, LDH and Lipase assays.
Published
2020-07-15
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

Contact Domains

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
05055273216486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055273216486050552732164865055273216486

GMDN Terms

TermDefinition
Multiple clinical chemistry enzyme IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple clinical chemistry enzymes.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-24 Degrees Celsius-18 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+442894451070technical.services@randox.com

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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05055273219067LIQUID CARDIAC CONTROL 3CQ10536CQ105362025-03-21
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