OralissTM Oral Fluid Drug Screen

GUDID 00858886006476

6AM4/AMP50/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10/THC40

NOBLE MEDICAL INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00858886006476
NIH Device Record Keye5092aa6-1545-4aa0-a2bd-65f20425bbd8
Commercial Distribution StatusIn Commercial Distribution
Brand NameOralissTM Oral Fluid Drug Screen
Version Model NumberDMDI-G810-006N
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
GS100858886006476 [Unit of Use]
GS110858886006473 [Primary]

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-31
Device Publish Date2020-03-23

On-Brand Devices [OralissTM Oral Fluid Drug Screen]

008588860064766AM4/AMP50/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10/THC40
00858886006469AMP50/COC20/MET50/OPI40/PCP10/THC40
00858886006490AMP50/BAR50/BUP5/BZO10/COC20/MET50/MTD30/OPI40/OXY20/PCP10/THC50(parent)/ALC(0.02%)
00858886006520AMP50/BAR50/BZO10/COC20/MET50/MTD30/OPI40/OXY20/PCP10/THC50
008588860065446-AM10/AMP50/BAR50/BUP10/BZO10/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/THC50(parent)

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