ALFRED 60 SI 105.100

GUDID 08056040140291

ALIFAX SRL

Urine analyser IVD, laboratory
Primary Device ID08056040140291
NIH Device Record Keyaad8c207-8150-42ed-b17d-d8a2389af177
Commercial Distribution StatusIn Commercial Distribution
Brand NameALFRED 60
Version Model NumberALFRED 60
Catalog NumberSI 105.100
Company DUNS435930630
Company NameALIFAX SRL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108056040140291 [Primary]

FDA Product Code

JTAMonitor, Microbial Growth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-14
Device Publish Date2022-10-06

Devices Manufactured by ALIFAX SRL

08056040148778 - LIGHT SCATTERING TEST KIT2022-10-28
08056040148945 - TEST1 2.02022-10-21
08056040140024 - LATEX CONTROLS2022-10-14
08056040140031 - LATEX CONTROLS2022-10-14
08056040140048 - LATEX CALIBRATORS2022-10-14
08056040140086 - URO-QUICK SCREENING KIT2022-10-14
08056040140291 - ALFRED 602022-10-14
08056040140291 - ALFRED 602022-10-14
08056040140307 - HB&L UROQUATTRO2022-10-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.