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 |
00810039380307 - Cholestech LDX™ | 2023-12-28 Cholestech LDX™ Analyzer |
00810039380512 - Cholestech LDX™ | 2023-12-28 Cholestech LDX™ Analyzer |
00893038002883 - Cholestech LDX™ | 2023-12-28 Cholestech LDX™ TC |
00893038002890 - Cholestech LDX™ | 2023-12-28 Cholestech LDX™ TC HDL |
00893038002906 - Cholestech LDX™ | 2023-12-28 Cholestech LDX™ TC GLU |
00893038002913 - Cholestech LDX™ | 2023-12-28 Cholestech LDX™ Lipid Profile |
00893038002920 - Cholestech LDX™ | 2023-12-28 Alere Cholestech LDX™ TC HDL GLU |
00893038002937 - Cholestech LDX™ | 2023-12-28 Cholestech LDX™ Lipid Profile GLU |