Noble 1 Step Cup NBCA-12M-W

GUDID 00858886006315

Drugs of Abuse Test Cup for (BZO/BAR)+(COC/THC)+(MET/OPI)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. (CLIA Waived)

NOBLE MEDICAL INC

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

• Primary Device ID: 00858886006315
• NIH Device Record Key: c344e767-7b81-4e32-b6f0-512298ef774f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Noble 1 Step Cup
• Version Model Number: NBCA-12M-W
• Catalog Number: NBCA-12M-W
• Company DUNS: 035967806
• Company Name: NOBLE MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858886006315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052115

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [Noble 1 Step Cup]

• 00858886006322: Drugs of Abuse Test Cup for THC50/C0C150/0PI300/mAMP500/AMP500/BZO300/BAR300/MTD300/MDMA500/OXY1
• 00858886006315: Drugs of Abuse Test Cup for (BZO/BAR)+(COC/THC)+(MET/OPI)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) with Cr
• 00858886006308: Drugs of Abuse Test Cup for (COC/THC)+(PCP/AMP)+BZO+OPI+OXY with Cr, Ni, pH, Bl, S.G. (CLIA Waiv
• 00858886006186: Drugs of Abuse Test Cup for (COC/THC)+(MET/OPI)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr,