INSTA-SCREEN-2TM Cup

GUDID 10858886006435

AMP500/COC150/MOR300/PCP25/THC50

NOBLE MEDICAL INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10858886006435
NIH Device Record Key6eef549a-8df2-43ef-af05-266d0a3806eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameINSTA-SCREEN-2TM Cup
Version Model NumberIS2-DJO-154L
Company DUNS035967806
Company NameNOBLE MEDICAL INC
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS100858886006438 [Unit of Use]
GS110858886006435 [Primary]

FDA Product Code

LDJEnzyme Immunoassay, Cannabinoids

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-05-24
Device Publish Date2018-09-12

On-Brand Devices [INSTA-SCREEN-2TM Cup]

10858886006459AMP500/BAR300/BZO300/COC150/MET500/MOR300/MTD300/OXY100/PCP25/THC50
10858886006442AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/MOR300/MTD300/OXY100/PCP25/TCA1000/THC5
10858886006435AMP500/COC150/MOR300/PCP25/THC50
10858886006428AMP500/COC150/MET500/MOR300/THC50
10858886006411AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MOR300/MTD300/OXY100/PCP25/TCA1000/THC50
10858886006404AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MOR300/MTD300/OXY100/PCP25/TCA1000/THC50/(CR/OX/pH)

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