HB&L UROQUATTRO SI 190.300

GUDID 08056040140307

ALIFAX SRL

Urine analyser IVD, laboratory
Primary Device ID08056040140307
NIH Device Record Keycabd16b2-dead-4f0b-adb1-935456b12f7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHB&L UROQUATTRO
Version Model NumberHB&L UROQUATTRO
Catalog NumberSI 190.300
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 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108056040140307 [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
08056040140307 - HB&L UROQUATTRO2022-10-14
08056040140307 - HB&L UROQUATTRO2022-10-14

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