Chemtrue 711A31-CT
GUDID 00812203030643
Chemtrue FYL5 Dip Card Test, 25pcs/kit
CHEMTRON BIOTECH INC
Multiple drugs of abuse IVD, kit, rapid ICT, clinical| Primary Device ID | 00812203030643 |
| NIH Device Record Key | 9332b3d1-6c01-4c6d-aea9-e523075c1dc7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Chemtrue |
| Version Model Number | 711A31-CT |
| Catalog Number | 711A31-CT |
| 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 | 00812203030643 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K232736
FDA Product Code
| DJG | Enzyme Immunoassay, Opiates |
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 | 2024-02-09 |
| Device Publish Date | 2024-02-01 |
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 |
Trademark Results [Chemtrue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHEMTRUE 86193167 4756983 Live/Registered |
Chemtron Biotech, Inc. 2014-02-13 |
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