FDA Registration
Active
🇺🇸 United States
IMMUNOSTICS, INC.
Reg #: 2244821
·
FEI: 2244821
·
Expires 2026
Products
19
Proprietary Names
13
Establishment Types
5
Classifications
19
Registration Details
- Registration Name
- IMMUNOSTICS, INC.
- Registration Number
- 2244821
- FEI Number
- 2244821
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 38 Industrial Way E Ste 1
- City
- Eatontown
- State
- NJ
- ZIP
- 07724
- Country
- US
Regulatory Submissions
- 510(k) Number
- K905782
Owner / Operator
- Firm Name
- IMMUNOSTICS, INC.
- Operator Number
- 2244821
- Address
- 38 INDUSTRIAL WAY EAST, SUITE 1, --
- City
- Eatontown
- State
- NJ
- Postal Code
- 07724
- Country
- US
- Correspondent
- Young Mi Kim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2015-08-24 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2018-11-27 |
| Control, Hemoglobin | GGM | Class 2 | Hematology | No | 2018-11-27 |
| System, Test, Infectious Mononucleosis | KTN | Class 2 | Immunology | No | 2015-08-24 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2015-08-24 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2018-10-18 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2018-10-18 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2018-10-18 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2018-10-18 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2018-10-18 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2018-10-18 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2018-10-18 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2018-10-18 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2018-10-18 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2018-10-18 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2018-10-18 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2019-06-27 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2015-08-25 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2015-08-24 |
Proprietary Names
hema-screen Specific Gold
hemochroma PLUS Analyzer
hemochroma PLUS Analyzer Promo Kit
hemochroma PLUS Optical System Check
hemochroma PLUS Control
hemochroma PLUS Microcuvettes
hema-screen ER XCEL Enhanced Readability FOBT
hema screen SPECIFIC
ALFIS Vitamin D
hema-screen
hCG Control Kit
hema-screen SPECIFIC GOLD Hemoglobin Controls
Detector RPR Control Kit
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only