Alinity 07P8431
GUDID 00380740136666
Alinity i Anti-HBc Reagent Kit 1200 Tests
Abbott GmbH & Co. KG
Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay| Primary Device ID | 00380740136666 |
| NIH Device Record Key | 5d075c27-644c-4432-bc7e-9a45126d842a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alinity |
| Version Model Number | 07P8431 |
| Catalog Number | 07P8431 |
| Company DUNS | 315786293 |
| Company Name | Abbott GmbH & Co. KG |
| 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 |
Customer Support Contacts
| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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| Phone | +1(877)422-2688 |
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Operating and Storage Conditions
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00380740136666 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P080023
FDA Product Code
| LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
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 | 2019-10-21 |
| Device Publish Date | 2019-10-11 |
On-Brand Devices [Alinity]
| 00380740166441 | Alinity c Lithium Assay File |
| 00380740162832 | Alinity c Bili Total Assay File |
| 00380740161941 | Alinity c UIBC Assay File |
| 00380740160807 | Alinity i B_hCG Assay File |
| 00380740160791 | Alinity c Iron Assay File |
| 00380740158460 | Alinity ci-series Reagent Cartridge, Black (Large) |
| 00380740158422 | Alinity c Total Bilirubin Reagent Kit 3600 Tests |
| 00380740158415 | Alinity c Total Bilirubin Reagent Kit 2750 Tests |
| 00380740155919 | Alinity i CA 19-9XR Reagent Kit 200 Tests |
| 00380740155797 | Alinity i tHCY-DIL Assay File |
| 00380740154493 | Alinity i C-Peptide Reagent Kit 200 Tests |
| 00380740154486 | Alinity i Homocysteine Controls |
| 00380740154479 | Alinity i Homocysteine Calibrators |
| 00380740154462 | Alinity i C-Peptide Calibrators |
| 00380740154325 | Alinity c Lipid Multiconstituent Calibrator Kit |
| 00380740153526 | Alinity i C-Peptide Controls |
| 00380740153496 | Alinity i Homocysteine Reagent Kit 200 Tests |
| 00380740153458 | Alinity c-series Detergent B |
| 00380740152864 | Alinity c Iron Calibrator Kit |
| 00380740152123 | Alinity c Valproic Assay File |
| 00380740152109 | Alinity c Tobra Assay File |
| 00380740152093 | Alinity c Theo Assay File |
| 00380740152062 | Alinity c Prealbumin Assay File |
| 00380740152055 | Alinity c Phenobarb Assay File |
| 00380740151843 | Alinity c ASO Assay File |
| 00380740151812 | Alinity c Amikacin Assay File |
| 00380740151799 | Alinity c a1AT Assay File |
| 00380740151768 | Alinity c B2M Assay File |
| 00380740151737 | Alinity i SHBG Assay File |
| 00380740151706 | Alinity i Progest Assay File |
| 00380740151690 | Alinity i PCT Assay File |
| 00380740151621 | Alinity i LH Assay File |
| 00380740151614 | Alinity i Insulin Assay File |
| 00380740151607 | Alinity i tHCY-UNDIL Assay File |
| 00380740151553 | Alinity i FSH Assay File |
| 00380740151485 | Alinity i C-Peptide Assay File |
| 00380740151447 | Alinity i VitB12 Assay File |
| 00380740151430 | Alinity i Anti-TPO Assay File |
| 00380740151423 | Alinity i Anti-Tg Assay File |
| 00380740151416 | Alinity i Anti-CCP Assay File |
| 00380740151393 | Alinity i SHBG Reagent Kit |
| 00380740151386 | Alinity i SHBG Controls |
| 00380740151379 | Alinity i SHBG Calibrators |
| 00380740151362 | Alinity i Anti-CCP Reagent Kit 200 Tests |
| 00380740151355 | Alinity i Anti-CCP Controls |
| 00380740151348 | Alinity i Anti-CCP Calibrators |
| 00380740151256 | Alinity c Prealbumin Calibrator Kit |
| 00380740151089 | Alinity c Specific Proteins Multiconstituent Calibrator Kit |
| 00380740150914 | Alinity i Testo 2G Assay File |
| 00380740150815 | Alinity i Insulin Reagent Kit 200 Tests |
Trademark Results [Alinity]
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 |
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