OSTS 712L01OS

GUDID 00850019007008

OSTS 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/ PCP/THC, 25pcs/kit

CHEMTRON BIOTECH INC

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

• Primary Device ID: 00850019007008
• NIH Device Record Key: 7f9f04d1-9bdd-496d-8227-1552fb4babef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSTS
• Version Model Number: 712L01OS
• Catalog Number: 712L01OS
• Company DUNS: 795658603
• Company Name: CHEMTRON BIOTECH 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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 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	00850019007008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142396

FDA Product Code

• DJR: Enzyme Immunoassay, Methadone

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: 2016-06-23

On-Brand Devices [OSTS]

• 00850019007930: 13-Panel DOA Cup, AMP/BAR/BUP/BZO/COC/MDMA/MET500/MTD/MOR300/OXY/PCP/TCA/THC/A-Strip (Cr/SG/Bl/N
• 00850019007411: OSTS 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/PCP/THC, 25pcs/
• 00850019007022: OSTS 12-Panel Drug Screen Dip Card Tests COC/MOR300/MET/THC/AMP/PCP/BZO/BAR/ MTD/OXY/MDMA/BUP, 2
• 00850019007008: OSTS 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/ PCP/THC, 25pcs
• 00812203030377: OSTS 11-Panel DOA Dip Test AMP500/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR/OXY/PCP