OralissTM Oral Fluid Drug Screen

GUDID 00858886006490

AMP50/BAR50/BUP5/BZO10/COC20/MET50/MTD30/OPI40/OXY20/PCP10/THC50(parent)/ALC(0.02%)

NOBLE MEDICAL INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00858886006490
• NIH Device Record Key: 967b9dc9-9c68-4feb-a0c9-1fb8255a1302
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OralissTM Oral Fluid Drug Screen
• Version Model Number: DMDI-G811-001n
• Company DUNS: 035967806
• Company Name: NOBLE MEDICAL INC
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858886006490 [Unit of Use]
GS1	10858886006497 [Primary]

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-14
• Device Publish Date: 2021-12-06

On-Brand Devices [OralissTM Oral Fluid Drug Screen]

• 00858886006476: 6AM4/AMP50/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10/THC40
• 00858886006469: AMP50/COC20/MET50/OPI40/PCP10/THC40
• 00858886006490: AMP50/BAR50/BUP5/BZO10/COC20/MET50/MTD30/OPI40/OXY20/PCP10/THC50(parent)/ALC(0.02%)
• 00858886006520: AMP50/BAR50/BZO10/COC20/MET50/MTD30/OPI40/OXY20/PCP10/THC50
• 00858886006544: 6-AM10/AMP50/BAR50/BUP10/BZO10/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/THC50(parent)