Primary Device ID | 00380740173555 |
NIH Device Record Key | e91e707a-82e0-44b9-934f-9d84075d702d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Alinity |
Version Model Number | 07P8852 |
Catalog Number | 07P8852 |
Company DUNS | 985307301 |
Company Name | Abbott Ireland Diagnostics |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
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 | +1(877)422-2688 |
xx@xx.xx | |
Phone | +1(877)422-2688 |
xx@xx.xx | |
Phone | +1(877)422-2688 |
xx@xx.xx | |
Phone | +1(877)422-2688 |
xx@xx.xx | |
Phone | +1(877)422-2688 |
xx@xx.xx | |
Phone | +1(877)422-2688 |
xx@xx.xx | |
Phone | +1(877)422-2688 |
xx@xx.xx | |
Phone | +1(877)422-2688 |
xx@xx.xx | |
Phone | +1(877)422-2688 |
xx@xx.xx | |
Phone | +1(877)422-2688 |
xx@xx.xx | |
Phone | +1(877)422-2688 |
xx@xx.xx | |
Phone | +1(877)422-2688 |
xx@xx.xx | |
Phone | +1(877)422-2688 |
xx@xx.xx |
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 |
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 |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00380740173555 [Primary] |
LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2023-12-11 |
Device Publish Date | 2023-01-06 |
00380740153953 | Alinity i BRAHMS PCT Reagent Kit 200 Tests |
00380740153946 | Alinity i BRAHMS PCT Controls |
00380740153939 | Alinity i BRAHMS PCT Calibrators |
00380740153892 | Alinity i Anti-TPO Reagent Kit 200 Tests |
00380740150600 | Alinity i Anti-TPO Controls |
00380740150594 | Alinity i Anti-TPO Calibrators |
00380740150587 | Alinity i Anti-Tg Controls |
00380740150570 | Alinity i Anti-Tg Calibrators |
00380740149550 | Alinity i Anti-Tg Reagent Kit 200 Tests |
00380740136529 | Alinity i-series Probe Conditioning Solution |
00380740135478 | Alinity i T-Uptake Controls |
00380740131678 | Alinity i Multi-Assay Manual Diluent |
00380740131548 | Alinity i T-Uptake Reagent Kit 200 Tests |
00380740131531 | Alinity i T-Uptake Calibrators |
00380740130862 | Alinity i CEA Reagent Kit 1200 Tests |
00380740130855 | Alinity i CEA Reagent Kit 200 Tests |
00380740130848 | Alinity i CEA Controls |
00380740130831 | Alinity i CEA Calibrators |
00380740130060 | Alinity i Cortisol Reagent Kit 1000 Tests |
00380740130053 | Alinity i Cortisol Reagent Kit 200 Tests |
00380740130046 | Alinity i Cortisol Calibrators |
00380740121143 | Alinity i-series Concentrated Wash Buffer |
00380740118174 | Alinity Pre-Trigger Solution |
00380740118167 | Alinity Trigger Solution |
00380740174927 | Alinity i STAT CK-MB Reagent Kit 200 Tests |
00380740165505 | Alinity i STAT CK-MB Controls |
00380740165482 | Alinity i STAT CK-MB Calibrators |
00380740151300 | Alinity i Anti-HBs Controls |
00380740149611 | Alinity i Anti-HBs Reagent Kit 1200 Tests |
00380740149604 | Alinity i Anti-HBs Reagent Kit 200 Tests |
00380740149598 | Alinity i Anti-HBs Specimen Diluent |
00380740149574 | Alinity i Anti-HBs Calibrators |
00380740136819 | Alinity s HBsAg Reagent Kit |
00380740136802 | Alinity s HBsAg Release Control Kit |
00380740136796 | Alinity s HBsAg Assay Control Kit |
00380740136789 | Alinity s HBsAg Confirmatory Reagent Kit |
00380740136772 | Alinity s HBsAg Calibrator Kit |
00380740130824 | Alinity i AFP Reagent Kit 1200 Tests |
00380740130817 | Alinity i AFP Reagent Kit 200 Tests |
00380740130800 | Alinity i AFP Controls |
00380740130794 | Alinity i AFP Calibrators |
00380740174941 | Alinity i STAT CK-MB Reagent Kit 1000 Tests |
00380740174910 | Alinity i STAT Myoglobin Reagent Kit 1000 Tests |
00380740174903 | Alinity i STAT Myoglobin Reagent Kit 200 Tests |
00380740172282 | Alinity i STAT Myoglobin Controls |
00380740172275 | Alinity i STAT Myoglobin Calibrators |
00380740136895 | Alinity s Optics Verifier Kit |
00380740118181 | Alinity s Concentrated Wash Buffer |
00380740146245 | Alinity i HBsAg Qualitative II Controls |
00380740146238 | Alinity i HBsAg Qualitative II Calibrators |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ALINITY 97548714 not registered Live/Pending |
Matthew Kubicek 2022-08-15 |
ALINITY 86505125 not registered Dead/Abandoned |
Abbott Laboratories 2015-01-15 |
ALINITY 86505124 5908335 Live/Registered |
Abbott Laboratories 2015-01-15 |
ALINITY 86505123 not registered Dead/Abandoned |
Abbott Laboratories 2015-01-15 |
ALINITY 86505098 not registered Dead/Abandoned |
Abbott Laboratories 2015-01-15 |
ALINITY 86505096 5576114 Live/Registered |
Abbott Laboratories 2015-01-15 |
ALINITY 86505094 5607328 Live/Registered |
Abbott Laboratories 2015-01-15 |
ALINITY 86505092 5601535 Live/Registered |
Abbott Laboratories 2015-01-15 |
ALINITY 86505089 5601534 Live/Registered |
Abbott Laboratories 2015-01-15 |
ALINITY 86505088 5601533 Live/Registered |
Abbott Laboratories 2015-01-15 |
ALINITY 86456946 not registered Dead/Abandoned |
WORKFRONT, INC. 2014-11-17 |
ALINITY 85043533 not registered Dead/Abandoned |
JBZ&A, Inc. 2010-05-20 |