FDA.report

iPeak® reader 4,3" Lateral Flow Reader

Primary DI
08437022431482
Brand
iPeak® reader 4,3" Lateral Flow Reader
Company
IUL SA
Model
100033000US1
Catalog number
900033000US1
Device description
The iPeak® reader 4,3” Lateral Flow Reader (SW Version 3.0) is an instrument specifically to be used to provide quantitative, semi-quantitative, and/or qualitative in-vitro determination of photometric immunochromatographic test defined and marketed by IUL’ partners. The iPeak® reader 4,3” is intended to be used only in combination with lateral flow (LF) tests indicated for use with the iPeak® reader 4,3”, and only for applications that are described in the respective handbooks of our reader associates.
Published
2022-02-14
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
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08437022431482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08437022431482084370224314828437022431482

GMDN Terms

TermDefinition
Photometric/spectroscopic immunoassay analyser IVDA portable, electrically-powered instrument, intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in a clinical specimen. The instrument uses photometry and/or light spectroscopy to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by health professionals for rapid in vitro diagnostic measurements at the point-of-care or in the laboratory.

Device Sizes

TypeValueUnit
Height140Millimeter
Length145Millimeter
Weight0.6Kilogram
Width126.5Millimeter

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+34932740232iul@iul-inst.com

Regulatory Flags

DUNS number
468283860
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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