Primary Device ID | 00845533000048 |
NIH Device Record Key | 4416547d-5f8e-47ec-bb6f-303c7345bd7b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AtheNA Multi-Lyte® EBV-VCA IgM Plus Test System |
Version Model Number | A92101M |
Catalog Number | A92101M |
Company DUNS | 080953946 |
Company Name | ZEUS SCIENTIFIC, 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 | 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 |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00845533000048 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-02-21 |
Device Publish Date | 2016-09-24 |
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00845533001854 - ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test System | 2022-05-05 The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodi |
00845533000031 - AtheNA Multi-Lyte® EBV IgG Plus Test System | 2019-02-21 The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus (EBV) IgG Plus Test System is intended for the qualitative detection of IgG clas |
00845533000048 - AtheNA Multi-Lyte® EBV-VCA IgM Plus Test System | 2019-02-21The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus - Viral Capsid Antigen (EBV-VCA) IgM Plus Test System is a microparticle-based immunoassay intended for the qualitative detection of IgM class antibody to the Epstein-Barr virus, viral capsid antigen in human serum using the AtheNA Multi-Lyte System. The test system is intended to be used for the laboratory diagnosis of EBV-associated infectious mononucleosis and provides epidemiological information on the diseases caused by Epstein-Barr virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas. This test is for In Vitro diagnostic use only. |
00845533000048 - AtheNA Multi-Lyte® EBV-VCA IgM Plus Test System | 2019-02-21 The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus - Viral Capsid Antigen (EBV-VCA) IgM Plus Test System is a microparticle-based i |
00845533000499 - ELISA EBV-VCA IgM Test System | 2019-02-21 The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA) |
00845533000505 - ELISA EBV-VCA IgM Q Test System | 2019-02-21 The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA) |
00845533000512 - ELISA EBV-VCA IgM Smart Kit Test System | 2019-02-21 The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ATHENA MULTI-LYTE 76665931 3284216 Dead/Cancelled |
Zeus Scientific, Inc. 2006-09-11 |
ATHENA MULTI-LYTE 76665930 3267101 Live/Registered |
Zeus Scientific, Inc. 2006-09-11 |
ATHENA MULTI-LYTE 76091059 2813370 Dead/Cancelled |
Zeus Scientific, Inc. 2000-07-18 |