FDA.report

Optilite® Analyser

Primary DI
05051700020893
Brand
Optilite® Analyser
Company
THE BINDING SITE GROUP LIMITED
Model
IE700
Published
2022-07-22
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
false

Related Records

Contact Domains

Product Codes

CodeName
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05051700020893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05051700020893050517000208935051700020893

GMDN Terms

TermDefinition
Nephelometry/turbidimetry analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of light absorption and/or light scatter caused by particles (e.g., bacteria) and/or other biological components suspended in a clinical specimen using a photometric detection system. It is generally used to measure the concentration of a target analyte in solution. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature13 Degrees Celsius27 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+4401214569500info@bindingsite.co.uk

Regulatory Flags

DUNS number
347045614
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05051700020695EXENT® Wash solution 1 IK8222025-11-27
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05051700019392Optilite® Low Level Total Protein ControlsNQ061.L.OPT2024-10-30
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