FDA.reportPublic FDA data

SERUM INDICES (SERUM INDICES)

Primary DI
05055273217025
Brand
SERUM INDICES (SERUM INDICES)
Company
RANDOX LABORATORIES LIMITED
Model
SI10448
Catalog number
SI10448
Device description
Intended for in vitro diagnostic (IVD) use to monitor the instrument’s response in detecting haemolyzed, icteric and lipemic samples.
Published
2022-09-23
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
05055273217025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055273217025050552732170255055273217025

GMDN Terms

TermDefinition
Chromogen indicator IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative indication of chromogens in a clinical specimen, using a spectrophotometry method. This test is typically used in the assessment of lipaemia, turbidity, icterus caused by bilirubin and/or haemolysis of red blood cells.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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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