Chemtrue 711A09CT

GUDID 00850019007237

Chemtrue® BZO Dip Card Test, 25pcs/kit

CHEMTRON BIOTECH INC

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

• Primary Device ID: 00850019007237
• NIH Device Record Key: a9eb159d-91b3-4265-83fe-6179a8700711
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chemtrue
• Version Model Number: 711A09CT
• Catalog Number: 711A09CT
• 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	00850019007237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142396

FDA Product Code

• JXM: Enzyme Immunoassay, Benzodiazepine

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: 2016-06-24

On-Brand Devices [Chemtrue]

• 00850019007954: Chemtrue 6-Panel DOA Cup, AMP/BZO/COC/MET/MOR300/OXY, 25 tests/kit
• 00850019007947: Chemtrue 7-Panel DOA Cup, AMP/BAR/BZO/COC/MET/MOR300/OXY , 25tests/kit
• 00850019007732: Chemtrue 10-Panel DOA Dip Card, AMP/BAR/BZO/COC/MET/MTD/OPI2000/OXY/PCP/THC, 25 tests/kit
• 00850019007619: 13-Panel DOA Cup, AMP/BAR/BUP/BZO/COC/MET500/MTD/OPI300/OXY/PCP/PPX/TCA/THC - Chemtrue, 25tests/
• 00850019007527: Chemtrue® 6-Panel DOA Cup Test, THC/MOR300/BZO/MET/AMP/COC, 25pcs/kit
• 00850019007510: Chemtrue® 6-Panel DOA Cup Test, AMP/COC/MET/MOR300/OXY/THC, 25pcs/kit
• 00850019007381: Chemtrue® 10-Panel Drug Screen Dip Card Tests, AMP/BAR/BZO/COC/MDMA/MET/MTD/MOR300/PCP/ THC, 25
• 00850019007374: Chemtrue® 9-Panel Drug Screen Dip Card Tests with A-Strip, AMP/BAR/BZO/COC/MET/MTD/MOR300/PCP/T
• 00850019007367: Chemtrue® 8-Panel Drug Screen Dip Card Tests, AMP/BUP/BZO/COC/MET/MTD/MOR300/OXY, 25pcs/kit
• 00850019007336: Chemtrue® 5-Panel Drug Screen Dip Card Tests, BZO/COC/MET/MOR300/THC, 25pcs/kit
• 00850019007312: Chemtrue® 5-Panel Drug Screen Dip Card Tests, AMP/COC/ MET/MOR300/ THC, 25pcs/kit
• 00850019007282: Chemtrue® 3-Panel Drug Screen Dip Card Tests, COC/MET/THC, 25pcs/kit
• 00850019007268: Chemtrue® 2-Panel Drug Screen Dip Card Tests, COC/THC, 25pcs/kit
• 00850019007251: Chemtrue® MOR300 Dip Card Test, 25pcs/kit
• 00850019007244: Chemtrue® OXY Dip Card Test , 25pcs/kit
• 00850019007237: Chemtrue® BZO Dip Card Test, 25pcs/kit
• 00850019007220: Chemtrue® BAR Dip Card Test, 25pcs/kit
• 00850019007213: Chemtrue® MDMA Dip Card Test, 25pcs/kit
• 00850019007206: Chemtrue® THC Dip Card Test, 25pcs/kit
• 00850019007190: Chemtrue® PCP Dip Card Test, 25pcs/kit
• 00850019007183: Chemtrue® MET Dip Card Test, 25pcs/kit
• 00850019007176: Chemtrue® COC Dip Card Test, 25pcs/kit
• 00850019007169: Chemtrue® AMP Dip Card Test, 25pcs/kit
• 00850019007152: Chemtrue® BUP Dip Card Test, 25pcs/kit
• 00850019007015: Chemtrue® 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/PCP/THC,
• 00812203030483: 7-Panel Chemtrue DOA Cup, AMP/COC/MET500/OPI300/OXY/PCP/THC + (Cr/SG/Ox)(Ni/pH/Gl)
• 00812203030513: Chemtrue 7-Panel DOA Dip Card, BZO/COC150/MET500/MOR/OXY/PCP/THC (Ni/pH/Gl)(Cr/SG/Ox)
• 00812203030520: Chemtrue 12-Panel DOA Cup Test, AMP/BAR/BUP/BZO/COC150/MDMA/MET/MTD/OPI/OXY/PCP/THC + A-strip (C
• 00812203030551: Chemtrue 5-Panel DOA Cup, AMP500/COC150/MET500/OPI/PCP/(Cr/SG/Ox/Ni/pH/Gl)
• 00812203030643: Chemtrue FYL5 Dip Card Test, 25pcs/kit