INCUP 10-7SPC-283

GUDID 10694644450726

InCup with THC/OPI300/METH/BZO/MDMA/COC/BAR

AMERICAN BIO MEDICA CORPORATION

Multiple therapeutic drugs/drugs of abuse IVD, calibrator

• Primary Device ID: 10694644450726
• NIH Device Record Key: 37a4027f-f757-49bf-8641-611fd6a5f946
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INCUP
• Version Model Number: 10-7SPC-283
• Catalog Number: 10-7SPC-283
• Company DUNS: 966665036
• Company Name: AMERICAN BIO MEDICA CORPORATION
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10694644400721 [Primary]
GS1	10694644450726 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073078

FDA Product Code

• LAG: High Pressure Liquid Chromatography, Methamphetamine

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: 2020-08-21
• Device Publish Date: 2020-08-13

On-Brand Devices [INCUP]

• 10694644450726: InCup with THC/OPI300/METH/BZO/MDMA/COC/BAR
• 10694644450733: 6 P InCup/5P+Meth opi 300
• 10694644450740: Incup with AMP/COC/OPI300/OXY/THC/SVT