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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 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Detector hCG Stick | IHS-25 | FDA UDI | Class II | Active |
| hemochroma PLUS Microcuvettes | 100-202 | FDA UDI | Class II | Active |
| hema-screen | HSDV-8 | FDA UDI | Class II | Active |
| hema-screen | HS-100 | FDA UDI | Class II | Active |
| hema-screen ER developer | HSDVER-8 | FDA UDI | Class II | Active |
| Detector Lex RA | RA-100U | FDA UDI | Class II | Active |
| hema-screen SPECIFIC | HSSPCAS-10 | FDA UDI | Class II | Active |
| Detector Personal | IDP-3 | FDA UDI | Class II | Active |
| Detector UA 5 | IDU-5OB | FDA UDI | Class II | Active |
| Detector Lex RA | RA-50U | FDA UDI | Class II | Active |
| Detector C-Reactacol | CRC-50 | FDA UDI | Class II | Active |
| Detector Lex-IM | IMLX-25 | FDA UDI | Class II | Active |
| Detector Lex-IM | IMLX-50 | FDA UDI | Class II | Active |
| Detector Lex-CRP | CRP-100 | FDA UDI | Class II | Active |
| Detector hCG Combi | IDC-25 | FDA UDI | Class II | Active |
| Detector Color IM | IMC-100 | FDA UDI | Class II | Active |
| hema-screen SPECIFIC GOLD | HSGDCAS-25 | FDA UDI | Class II | Active |
| hema-screen | HS-50 | FDA UDI | Class II | Active |
| hema-screen Triple 335 | HSTR-335CS | FDA UDI | Class II | Active |
| Detector Rheumacol | RH-100 | FDA UDI | Class II | Active |
| Detector hCG Stick | IHS-100 | FDA UDI | Class II | Active |
| hemochroma PLUS Starter Kit | 100-PROMO | FDA UDI | Class II | Active |
| Detector UA 2 | IDU-2PG | FDA UDI | Class I | Active |
| hema-screen | HSPP-50 | FDA UDI | Class II | Active |
| Detector RPR | RPR-1003C | FDA UDI | Class II | Active |
| hema-screen SPECIFIC | HSSPCAS-25 | FDA UDI | Class II | Active |
| To Life | 2033 | FDA UDI | Class II | Active |
| hema-screen SPECIFIC GOLD | HSGDENV-20 | FDA UDI | Class II | Active |
| Am I Pregnant? | 5050M2-1B | FDA UDI | Class II | Active |
| hema-screen SPECIFIC | HSSPENV-20 | FDA UDI | Class II | Active |
| hema-screen | HS-100ND | FDA UDI | Class II | Active |
| hema-screen SPECIFIC GOLD | HSGD-25 | FDA UDI | Class II | Active |
| Detector Monocol Lex | MCLX-25 | FDA UDI | Class II | Active |
| hema-screen SPECIFIC | BUF17-25 | FDA UDI | Class II | Active |
| Detector Mono | IDM-25 | FDA UDI | Class II | Active |
| Detector C-Reactacol | CRC-100 | FDA UDI | Class II | Active |
| Detector UA 2GP | IDU-2GP | FDA UDI | Class II | Active |
| Detector RPR | RPR-5002C | FDA UDI | Class II | Active |
| Detector Rheumacol Lex | RHLX-50 | FDA UDI | Class II | Active |
| Detector hCG Personal | IDP-25 | FDA UDI | Class II | Active |
| Detector hCG Stick | IHS-25OR | FDA UDI | Class II | Active |
| Detector Personal | IDP-3 | FDA UDI | Class II | Active |
| Detector Lex SLE | SLE-50 | FDA UDI | Class II | Active |
| Detector RPR | RPR-100NC | FDA UDI | Class II | Active |
| Detector Rheumacol | RH-50 | FDA UDI | Class II | Active |
| Detector RPR | RPR-500NC | FDA UDI | Class II | Active |
| Detector Cept-D Polyclonal | 43100 | FDA UDI | Class II | Active |
| Detector hCG | IHD/P-100 | FDA UDI | Class II | Active |
| Hcg Detector Combi, Hcg Detector Stix, Hcg Detector Cassette | K041728 | FDA 510(k) | Class II | Active |
| Slide Pregnancy Test | K842110 | FDA 510(k) | Class II | Active |
Related Companies
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Authorities
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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. |