Generic

GUDID 00812203030797

13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MDMA/MET500/MTD/MOR/OXY/PCP/THC

CHEMTRON BIOTECH INC

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: 00812203030797
• NIH Device Record Key: 9a5885a6-37eb-4752-88aa-ea8c899ee8e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Generic
• Version Model Number: 712M09-G
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812203030797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232736

FDA Product Code

• LAF: Gas 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: 2024-08-06
• Device Publish Date: 2024-07-29

On-Brand Devices [Generic]

• 00812203030056: 13-Panel DOA Cup, AMP/BAR/BUP/BZO/COC/MET/MTD/OPI2000/OXY/PCP/PPX/TCA/THC - 25 tests/kit
• 00812203030049: 10-Panel DOA Cup, AMP/BAR/BZO/COC/MET/MTD/MOR/PCP/PPX/THC - 25tests/kit
• 00812203030032: 5-Panel DOA Cup Test, MTD/MOR/BUP/BZO/OXY, 25 tests/kit
• 00812203030025: 7-Panel DOA Cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC/A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25tests/kit
• 00812203030018: 5-Panel DOA Cup, AMP/COC/MET/OPI2000/THC /A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25tests/kit
• 00812203030001: 3-Panel DOA Cup, COC/THC/OPI2000/A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25 tests/kit
• 00850019007985: 8-Panel DOA Cup, BUP/BZO/COC/MET/MTD/MOR/OXY/THC, 25 tests/kit
• 00850019007978: 12-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/MDMA/MET500/MTD/MOR/OXY/TCA/THC, 25tests/kit
• 00850019007961: 4-Panel DOA Cup, AMP/COC/MET/THC, 25 Tests/kit
• 00850019007923: 11-Panel DOA Cup, AMP/BAR/BZO/BUP/COC/MET/MTD/MOR300/OXY/PCP/THC/A-Strip (Cr/SG/Bl), 25tests/kit
• 00850019007916: 9-Panel DOA Cup, AMP/BZO/COC/MET/MTD/MOR300/OXY/PCP/THC, 25tests/kit
• 00850019007909: 4-Panel DOA Dip Card, COC/THC/MET/AMP, 25 tests/kit
• 00850019007893: 9-Panel DOA Cup, AMP/BAR/BZO/COC/MET/MTD/OPI2000/PCP/THC/A-Strip (Cr/SG/Bl), 25 tests/kit
• 00850019007886: 9-Panel DOA Cup, AMP/BAR/BZO/COC/MET/MTD/OPI2000/PCP/THC, 25tests/kit
• 00850019007879: 11-Panel DOA Cup, AMP/BAR/BZO/COC/MET500/MTD/OPI2000/OXY/PCP/TCA/THC, 25tests/kit
• 00850019007862: 12-Panel DOA Cup, AMP/BAR/BZO/COC150/MDMA/MET500/MTD/MOR300/OXY/PCP/PPX/THC/A-Strip (Cr/SG/Bl),
• 00850019007855: 10-Panel DOA Cup, AMP/BAR/BZO/COC/MET/MTD/OPI2000/OXY/PCP/THC/A-Strip (Cr/SG/Bl), 25tests/kit
• 00850019007848: 10-Panel DOA Cup, AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI2000/OXY/PCP, 25tests/kit
• 00850019007831: OXY Dip Card Test, 25 tests/kit
• 00812203030148: 12-Panel DOA Cup, COC/AMP/MET/THC/MTD/MDMA/OPI/OXY/PPX/PCP/BAR/BZO
• 00812203030216: 12-Panel DOA Cup, AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI300/OXY/PCP/PPX/THC (Cr/SG/Bl)
• 00812203030209: 10-Panel DOA Cup, AMP/BAR/BZO/COC/MET/MTD/OPI300/PCP/PPX/THC(Cr/SG/Bl)
• 00812203030261: 12-Panel DOA Cup, AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Cr/Ox/pH)
• 00812203030254: 10-Panel DOA Cup, AMP500/BAR/BZO/COC150/MET500/MTD/MOR/PCP/PPX/THC(Cr/Ox/pH)
• 00812203030308: AMP300 Dip Card
• 00812203030322: 11-Panel Drug Screen Dip - AMP/BAR/BZO/COC/MET/MDMA/MOR/MTD/OXY/PCP/TCA
• 00812203030186: 14-Panel DOA Cup, THC/COC150/MOR/MET500/AMP500/BZO/BAR/MTD/BUP/TCA/MDMA/OXY/PCP/PPX
• 00812203030100: 10-Panel Drug Screen Dip - AMP/BAR/BZO/COC/THC/MTD/MOR/OXY/PCP/PPX
• 00812203030087: 12-Panel DOA Cup, THC/COC150/MOR/AMP500/MET500/BAR/BZO/BUP/MTD/MDMA/OXY/PCP
• 00812203030223: 5-Panel DOA Cup, COC/MET500/MOR/BZO/THC + (Ni/pH/Gl)/(Cr/SG/Bl)
• 00812203030667: 13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MDMA/MET/MTD/MOR/OXY/PCP/THC + A-strip (Cr/Ox/p
• 00812203030650: FYL5 Dip Card Test, 25pcs/kit
• 00812203030681: 11-Panel DOA Dip Card Test, AMP500/BAR/BZO/COC150/FYL5/MET500/MOR/MTD/OXY/PCP/THC+A-Strip(Ox/SG/
• 00812203030674: 14-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MET500/MDMA/MOR/MTD/OXY/PCP/THC/TML + A-strip (
• 00812203030711: 12-Panel DOA Dip, AMP/BZO/COC/MTD/MDMA/MET/MOR/OXY/BUP/TML/FYL5/THC
• 00812203030728: 11 Panel DOA Cup, AMP300/BZO200/BUP/COC150/MDMA/MET300/MTD/MOR/OXY/THC/FYL5/A-strips(Cr/SG/Ox)/(
• 00812203030759: TML Dip Card Test, 25pcs/kit
• 00812203030797: 13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MDMA/MET500/MTD/MOR/OXY/PCP/THC