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Sign in to claim this brandIMMUNOSTICS, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 38 Industrial Way E Ste 1, Eatontown, NJ, 07724
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2244821
- DUNS Number
- —
Catalogue (123)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Immuno/Febrile Antigens | K883685 | FDA 510(k) | Class II | Active |
| Colon Alert Test | K992759 | FDA 510(k) | Class II | Active |
| hemochroma PLUS System | K182298 | FDA 510(k) | Class II | Active |
| Immuno/Sle | K872910 | FDA 510(k) | Class II | Active |
| Immuno-Ra | K834391 | FDA 510(k) | Class II | Active |
| Hema Screen Er | K102664 | FDA 510(k) | Class II | Active |
| Immuno Ra Undiluted | K926569 | FDA 510(k) | Class II | Active |
| hemochroma PLUS System | K163465 | FDA 510(k) | Class II | Active |
| AFIAS iFOB with AFIAS-50 | K163225 | FDA 510(k) | Class II | Active |
| Rheumacol Rheumatoid Factor Test | K972456 | FDA 510(k) | Class II | Active |
| hema-screen SPECIFIC Gold | K171484 | FDA 510(k) | Class II | Active |
| Monocol/Lex-Im Test | K972457 | FDA 510(k) | Class II | Active |
| Pregnacol Pregnancy Test | K972606 | FDA 510(k) | Class II | Active |
| ALFIS Vitamin D, ALFIS-3 Analyzer | K221817 | FDA 510(k) | Class II | Active |
| Hema Screen Specific Ifobt | K060463 | FDA 510(k) | Class II | Active |
| Immuno-Crp | K834390 | FDA 510(k) | Class II | Active |
| Immuno-Cept D (beta-Monoclonal) | K863741 | FDA 510(k) | Class II | Active |
| Detectacult | K854619 | FDA 510(k) | Class II | Active |
| Hema-Screen | K902360 | FDA 510(k) | Class II | Active |
| hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | K163554 | FDA 510(k) | Class II | Active |
| Rubellacol | K031490 | FDA 510(k) | Class II | Active |
| Immuno-Im | K853105 | FDA 510(k) | Class II | Active |
| Immuno/Aso | K894780 | FDA 510(k) | Class I | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 25, 2023 | Z-0702-2024 | — | open, classified | Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive, false negative, or invalid results. |