Primary Device ID | 00845533000659 |
NIH Device Record Key | 96a4b741-d14e-424b-bd95-542237ef0da1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ELISA H. pylori IgG Smart Kit Test System |
Version Model Number | SM3Z51021G |
Catalog Number | SM3Z51021G |
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 | 00845533000659 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-24 |
00845533001885 - ZEUS ELISA VZV IgM 480 Test System | 2024-09-26 The ZEUS ELISA Varicella-Zoster Virus (VZV) IgM Test System is intended for the qualitative detection of VZV IgM antibody inhuma |
00845533001878 - ZEUS NTx Urine | 2023-04-26 An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen |
00845533001861 - ZEUS dIFine(R) | 2022-05-11 ZEUS dIFine® digital immunofluorescence system is an IFA imaging and pattern recognition instrument designed to acquire, analyz |
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 | 2019-02-21 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) |