| Primary Device ID | 00893038002180 |
| NIH Device Record Key | a50c35c1-046c-40b7-998c-d42d75f83a3d |
| Commercial Distribution Discontinuation | 2017-10-03 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Triage® |
| Version Model Number | 96100 |
| Catalog Number | 96100 |
| Company DUNS | 194854949 |
| Company Name | ALERE SAN DIEGO, 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 | true |
| 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 | false |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com | |
| Phone | +18773088287 |
| USproductsupport@alere.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00893038002180 [Primary] |
| GMO | Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-08-23 |
| Device Publish Date | 2016-09-21 |
| 10810124273832 - CERTUM One Step Multi-Drug Screen Panel | 2024-12-25 COC300/AMP1000/mAMP1000/THC50/OPI2000/BZO300 |
| 10810124273849 - CERTUM One Step Multi-Drug Screen Panel | 2024-12-25 COC300/AMP1000/mAMP1000/THC50/OPI2000/BZO300 |
| 10810124273856 - CERTUM One Step Multi-Drug Screen Panel | 2024-12-25 COC300/AMP1000/mAMP1000/THC50/OPI2000 |
| 10810124273863 - CERTUM One Step Multi-Drug Screen Panel | 2024-12-25 COC300/AMP1000/THC50 |
| 10810124273870 - CERTUM One Step Multi-Drug Screen Panel | 2024-12-25 COC300/THC50 |
| 10815845023148 - SureStep™ Urine Test Drug Screen Strip | 2024-12-25 SureStep™ Urine Test Drug Screen Strip, Cocaine (COC300) |
| 10815845023155 - SureStep™ Urine Test Drug Screen Strip | 2024-12-25 SureStep™ Urine Test Drug Screen Strip, Barbiturate (BAR300) |
| 10815845023162 - SureStep™ Urine Test Drug Screen Strip | 2024-12-25 SureStep™ Urine Test Drug Screen Strip, Phencyclidine (PCP 25) |