Noble Drug Test Cup with AD (Urine)

GUDID 00858886006834

AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/OXY100/PCP25/THC50(pH/OX/CR)

NOBLE MEDICAL INC

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: 00858886006834
• NIH Device Record Key: 5b594274-8e9c-4777-9b67-1de63a7b299a
• Commercial Distribution Discontinuation: 2080-11-02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Noble Drug Test Cup with AD (Urine)
• Version Model Number: NMCupD-10-16-BT
• 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	00858886006834 [Unit of Use]
GS1	10858886006831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122809

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: 2023-11-10
• Device Publish Date: 2023-11-02

On-Brand Devices [Noble Drug Test Cup with AD (Urine)]

• 00858886006568: AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50(CR/OX/pH)
• 00858886006629: AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/THC50(pH/OX/SG/GL/N
• 00858886006636: AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/THC50/(OX/pH/SG)
• 00858886006667: 6AM10/AMP500/COC150/MDMA500/MET500/OPI300/OXY100/PCP25/THC50
• 00858886006711: AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/THC50/(OX/pH/SG)
• 00858886006735: AMP500/COC150/MET500/OPI300/THC50
• 00858886006827: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000(pH/OX/SG)/(G
• 00858886006834: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/OXY100/PCP25/THC50(pH/OX/CR)