Noble 1 Step + Cup NBCA-13A-B

GUDID 00858886006285

Drugs of Abuse Test Cup for THC50/COC150; OPI300/MET500; AMP500/BZ0300; BZO300/MT300; MDMA500/OXY100; BUPG10/TCA1000; with Cr, Ni, pH, Bl, S.G.

NOBLE MEDICAL INC

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

• Primary Device ID: 00858886006285
• NIH Device Record Key: a469a0cd-bb5c-460d-80e6-8b52ad86971e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Noble 1 Step + Cup
• Version Model Number: NBCA-13A-B
• Catalog Number: NBCA-13A-B
• 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: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858886006285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122633

FDA Product Code

• LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-15
• Device Publish Date: 2016-09-01

Devices Manufactured by NOBLE MEDICAL INC

• 00858886006834 - Noble Drug Test Cup with AD (Urine): 2023-11-10 AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/OXY100/PCP25/THC50(pH/OX/CR)
• 00858886006827 - Noble Drug Test Cup with AD (Urine): 2023-10-30 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000(pH/OX/SG)/(GL/NI/CR)
• 00858886006803 - Noble Drug Test Cup (Urine): 2023-05-29 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25
• 00858886006797 - Noble Drug Test Cup (Urine): 2023-05-19 6AM10/AMP500/COC150/MDMA500/MET500/OPI300/OXY100/PCP25
• 00858886006780 - Noble Drug Test Cup (Urine): 2023-05-15 6AM10/AMP500/COC150/MDMA500/MET500/OPI300/OXY100/PCP25
• 00858886006773 - Noble Drug Test Cup (Urine): 2023-02-22 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000
• 00858886006766 - Noble Dip Card with AD (Urine): 2023-02-09 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/(OX/pH/SG)
• 00858886006759 - Oraliss TM Oral Fluid Drug Screen: 2022-11-07 AMP50/BAR50/COC20/MET50/OPI40