Primary Device ID | 10859035006016 |
NIH Device Record Key | eff89075-acdb-416c-b817-5ccbc2ac0ea0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IMMUNEX CRP® |
Version Model Number | 71S2 |
Company DUNS | 826027364 |
Company Name | ALERE NORTH AMERICA, LLC |
Device Count | 100 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-877-441-7440 |
ts.scr@alere.com | |
Phone | 1-877-441-7440 |
ts.scr@alere.com | |
Phone | 1-877-441-7440 |
ts.scr@alere.com | |
Phone | 1-877-441-7440 |
ts.scr@alere.com | |
Phone | 1-877-441-7440 |
ts.scr@alere.com | |
Phone | 1-877-441-7440 |
ts.scr@alere.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00859035006019 [Unit of Use] |
GS1 | 10859035006016 [Primary] |
DCN | System, Test, C-Reactive Protein |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2022-06-10 |
Device Publish Date | 2016-09-24 |
10859035006023 - DENCOCCULT™ III | 2022-11-28 |
10859035006016 - IMMUNEX CRP® | 2022-06-10 |
10859035006016 - IMMUNEX CRP® | 2022-06-10 |
10859035006238 - Acceava® Mono Cassette | 2022-06-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() IMMUNEX CRP 73342424 1312857 Live/Registered |
Carter-Wallace, Inc. 1981-12-18 |