LEUCINE ARYLAMIDASE (LAP)

GUDID 05055273204063

RANDOX LABORATORIES LIMITED

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Primary Device ID05055273204063
NIH Device Record Keyb2ae1795-5f17-4e66-b056-67dec0c1fbf6
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEUCINE ARYLAMIDASE (LAP)
Version Model NumberLA561
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273204063 [Primary]

FDA Product Code

JGGL-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-11
Device Publish Date2019-06-03

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