ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM
FDA premarket approval P150042 · decided 2017-09-19
Approval details
- PMA number
- P150042
- Trade name
- ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Applicant
- Zeus Scientific, Inc.
- Date received
- 2015-11-19
- Decision date
- 2017-09-19
- Days to decision
- 670 days
- Decision code
- APPR
- Product code
- MYM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Branchburg, NJ
- Statement
- Approval for the ZEUS ELISA Parvovirus B19 IgM Test System is intended for the qualitative detection of IgM class antibodies to human parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human parvovirus B19. The test is also for all symptomatic patients as an aid in the diagnosis of fifth disease (erythema infectiosum). This test is for in vitro diagnostic use only.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Zeus IFA ANA HEp-2 Test System, Zeus dIFine (K201956) | Zeus Scientific, Inc. | 2022-04-29 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System (K190907) | Zeus Scientific, Inc. | 2019-07-29 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System (K191398) | Zeus Scientific, Inc. | 2019-07-29 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System (K191240) | Zeus Scientific, Inc. | 2019-07-29 |
| ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM (K113397) | Zeus Scientific, Inc. | 2012-07-26 |
| ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM (K102425) | Zeus Scientific, Inc. | 2011-12-12 |
| ZEUS ELISA HSV GG-2 IGG TEST SYSTEM (K103603) | Zeus Scientific, Inc. | 2011-05-20 |
| ZEUS ELISA HSV GC-I IGG TEST SYSTEM (K103363) | Zeus Scientific, Inc. | 2011-04-26 |