AMMONIA (NH3) AM1015

GUDID 05055273200256

RANDOX LABORATORIES LIMITED

Ammonia IVD, kit, enzyme spectrophotometry
Primary Device ID05055273200256
NIH Device Record Keybd384fa1-40f5-463e-b69f-0fe708e669e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMMONIA (NH3)
Version Model NumberAM1015
Catalog NumberAM1015
Company DUNS227530649
Company NameRANDOX LABORATORIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273200256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JIFEnzymatic Method, Ammonia

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-12
Device Publish Date2019-06-04

On-Brand Devices [AMMONIA (NH3)]

05055273200263AM1054
05055273200256AM1015

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