Data / Medical devices / United States / Immunostics, Inc.
Immunostics, Inc.: FDA-registered device maker in Eatontown, NJ, United States, 11 510(k) clearances
Immunostics, Inc. is registered with the FDA (registration 2244821) in Eatontown, NJ, United States. It lists 19 device types. The FDA files 11 510(k) clearances under its listings, the newest dated November 16, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2244821
- Address
- 38 Industrial Way E Ste 1, Eatontown, NJ, United States, 07724
- Owner or operator
- IMMUNOSTICS, INC. (2244821)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- April 23, 2008
- Registered through
- 2026
- Brand names listed
- ALFIS Vitamin D, Detector RPR Control Kit, hCG Control Kit, hema screen SPECIFIC, hema-screen, hema-screen ER XCEL Enhanced Readability FOBT, hema-screen SPECIFIC GOLD Hemoglobin Controls, hema-screen Specific Gold and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antigens, All Groups, Streptococcus Spp. | GTY | 1 | Complaint file establishment | accessdata.fda.gov |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Blood, Occult, Colorimetric, In Urine | JIO | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Control, Hemoglobin | GGM | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Helicobacter Pylori | LYR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Multi-Analyte Controls Unassayed | OHQ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Reagent, Occult Blood | KHE | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Refractometer For Clinical Use | JRE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| System, Hemoglobin, Automated | GKR | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, Test, Infectious Mononucleosis | KTN | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| System, Test, Vitamin D | MRG | 2 | Manufacturer for export | accessdata.fda.gov |
| Test, Urine Leukocyte | LJX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 16, 2018 | K182298 | hemochroma PLUS System | GKR | Substantially Equivalent | Immunostics Inc., | accessdata.fda.gov |
| September 8, 2017 | K163465 | hemochroma PLUS System | GKR | Substantially Equivalent | Immunostics Inc., | accessdata.fda.gov |
| June 14, 2017 | K171484 | hema-screen SPECIFIC Gold | KHE | Substantially Equivalent | Immunostics Inc., | accessdata.fda.gov |
| January 17, 2017 | K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | KHE | Substantially Equivalent | Immunostics Inc., | accessdata.fda.gov |
| August 11, 2006 | K061559 | ACON URINALYSIS REAGENT STRIPS | CDM | Substantially Equivalent | Acon Laboratories Co. | accessdata.fda.gov |
| June 6, 2006 | K060463 | HEMA SCREEN SPECIFIC IFOBT | KHE | Substantially Equivalent | Immunostics Inc., | accessdata.fda.gov |
| May 7, 2001 | K010582 | ACON STREP A RAPID TEST STRIP | GTY | Substantially Equivalent | Acon Laboratories Co. | accessdata.fda.gov |
| September 22, 1998 | K980798 | BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST | LYR | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| February 4, 1997 | K961024 | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB | KTN | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| May 6, 1991 | K905782 | FHT (FECAL HEME TEST) | KHE | Substantially Equivalent | Aerscher, Inc. | accessdata.fda.gov |
| July 27, 1990 | K902360 | HEMA-SCREEN | KHE | Substantially Equivalent | Immunostics Co., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 25, 2023 | 93646 | Class II | Ongoing | Detector H. Pylori, Catalog Number IHP-30 | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Infectious Mononucleosis
- All makers of Multi-Analyte Controls Unassayed
- All makers of Reagent, Occult Blood
- All makers of Helicobacter Pylori
- All makers of Dye-Indicator, Ph (Urinary, Non-Quantitative)
- All makers of Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
Updated January 10, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.