Immunostics Inc.,
Medical device manufacturer in Eatontown, NJ.
25510(k) clearances
0PMA approvals
1recalls
Device types
- KHE Reagent, Occult Blood 7
- DHR System, Test, Rheumatoid Factor 3
- JHJ Agglutination Method, Human Chorionic… 3
- KTN System, Test, Infectious Mononucleosis 2
- GKR System, Hemoglobin, Automated 2
- DCN System, Test, C-Reactive Protein 1
- DHC System, Test, Systemic Lupus Erythematosus 1
- GNC Antigens, Febrile, Slide And Tube, All… 1
- GTQ Antistreptolysin - Titer/Streptolysin O… 1
- LQN Latex Agglutination Assay, Rubella 1
- JHI Visual, Pregnancy Hcg, Prescription Use 1
- OOX Automated Occult Blood Analyzer 1
- MRG System, Test, Vitamin D 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K221817 | ALFIS Vitamin D, ALFIS-3 AnalyzerMRG · Traditional | 09/22/2023SE |
| K182298 | hemochroma PLUS SystemGKR · Traditional | 11/16/2018SE |
| K163465 | hemochroma PLUS SystemGKR · Traditional | 09/08/2017SE |
| K163225 | AFIAS iFOB with AFIAS-50OOX · Traditional | 08/08/2017SE |
| K171484 | hema-screen SPECIFIC GoldKHE · Special | 06/14/2017SE |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestKHE · Special | 01/17/2017SE |
| K102664 | Hema Screen ErKHE · Special | 01/28/2011SE |
| K060463 | Hema Screen Specific IfobtKHE · Traditional | 06/06/2006SE |
| K041728 | HCG Detector Combi, HCG Detector Stix, HCG Detector CassetteJHI · Traditional | 08/11/2004SE |
| K031490 | RubellacolLQN · Traditional | 07/16/2003SE |
| K992759 | Colon Alert TestKHE · Traditional | 12/06/1999SE |
| K972457 | Monocol/Lex-Im TestKTN · Traditional | 12/01/1997SE |
| K972456 | Rheumacol Rheumatoid Factor TestDHR · Traditional | 11/25/1997SE |
| K972606 | Pregnacol Pregnancy TestJHJ · Traditional | 08/29/1997SE |
| K926569 | Immuno Ra UndilutedDHR · Traditional | 04/06/1993SE |
| K902360 | Hema-ScreenKHE · Traditional | 07/27/1990SE |
| K894780 | Immuno/AsoGTQ · Traditional | 10/16/1989SE |
| K883685 | Immuno/Febrile AntigensGNC · Traditional | 09/28/1988SE |
| K872910 | Immuno/SleDHC · Traditional | 08/12/1987SE |
| K863741 | Immuno-Cept D (Beta-Monoclonal)JHJ · Traditional | 11/13/1986SE |
| K854619 | DetectacultKHE · Traditional | 03/03/1986SE |
| K853105 | Immuno-ImKTN · Traditional | 09/03/1985SE |
| K842110 | Slide Pregnancy TestJHJ · Traditional | 07/12/1984SE |
| K834391 | Immuno-RaDHR · Traditional | 02/03/1984SE |
| K834390 | Immuno-CrpDCN · Traditional | 02/03/1984SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0702-2024 Class II | Detector H. Pylori, Catalog Number IHP-30Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct… | 08/25/2023Open, Classified |