FDA Registration
Active
🇺🇸 United States
DRG International, Inc.
Reg #: 2245285
·
FEI: 2245285
·
Expires 2026
Products
94
Proprietary Names
172
Establishment Types
2
Classifications
94
Registration Details
- Registration Name
- DRG International, Inc.
- Registration Number
- 2245285
- FEI Number
- 2245285
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 841 Mountain Ave
- City
- Springfield
- State
- NJ
- ZIP
- 07081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K962055
Owner / Operator
- Firm Name
- BIOCHECK, INC.
- Operator Number
- 9033543
- Address
- 3451 Vincent Road, --
- City
- Pleasant Hill
- State
- CA
- Postal Code
- 94523
- Country
- US
- Correspondent
- Johanna - Saito
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2022-12-15 |
| Immunochemical, Lysozyme (Muramidase) | JMR | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | Class 2 | Immunology | No | 2022-12-15 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2022-12-16 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase) | JMQ | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | Class 2 | Immunology | No | 2026-05-11 |
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2022-12-15 |
| Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin | CDA | Class 1 | Clinical Chemistry | No | 2023-05-03 |
| Dengue Virus Antigen Assay | QCU | Class 2 | Microbiology | No | 2023-03-22 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2007-12-05 |
| Chromatography (Thin Layer), Clinical Use | KZS | Class 1 | Clinical Chemistry | No | 2022-12-16 |
| Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | LRM | Class 2 | Immunology | No | 2022-12-15 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2007-12-05 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2026-05-11 |
| System, Test, Anticardiolipin Immunological | MID | Class 2 | Immunology | No | 2022-12-15 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | LFY | Class 2 | Microbiology | No | 2022-12-16 |
| Sperm, Antigen, Antiserum, Control | DFQ | Class 1 | Immunology | No | 2022-12-14 |
| Elisa, Antibody, West Nile Virus | NOP | Class 2 | Microbiology | No | 2022-12-15 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2007-12-05 |
| Radioimmunoassay, Human Growth Hormone | CFL | Class 1 | Clinical Chemistry | No | 1998-04-22 |
| Epstein-Barr Virus, Other | LSE | Class 1 | Microbiology | No | 2022-12-16 |
| Wright'S Stain | IAF | Class 1 | Hematology | No | 2022-12-14 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2022-12-13 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2022-12-13 |
| Antiserum, Cf, Q Fever | GPR | Class 1 | Microbiology | No | 2022-12-14 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Apparatus, General Use, Thin Layer Chromatography | DPA | Class 1 | Clinical Chemistry | No | 2022-12-16 |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | Class 2 | Microbiology | No | 2022-12-16 |
| Radioimmunoassay, Androstenedione | CIZ | Class 1 | Clinical Chemistry | No | 2022-12-14 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 1998-04-22 |
| Thyroglobulin, Antigen, Antiserum, Control | DDC | Class 2 | Immunology | No | 2022-12-15 |
| Antiserum, Fluorescent, C. Diphtheriae | GOS | Class 1 | Microbiology | No | 2022-12-14 |
| Elisa, Trichinella Spiralis | MDT | Class 1 | Microbiology | No | 2022-12-15 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2022-12-12 |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | Class 2 | Immunology | No | 2022-12-16 |
| Antigen, Cf, Aspergillus Spp. | JWT | Class 1 | Microbiology | No | 2022-12-15 |
| Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | LIP | Class 2 | Microbiology | No | 2026-06-15 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| System, Test, Beta-2-Microglobulin Immunological | JZG | Class 2 | Immunology | No | 2007-12-05 |
| Radioimmunoassay, Estriol | CGI | Class 1 | Clinical Chemistry | No | 2022-12-14 |
| Lactoferrin, Antigen, Antiserum, Control | DEG | Class 1 | Immunology | No | 2022-12-14 |
| Antisera, Cf, Influenza Virus A, B, C | GNW | Class 1 | Microbiology | No | 2022-12-14 |
| Radioimmunoassay, Cortisol | CGR | Class 2 | Clinical Chemistry | No | 2026-05-18 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| 21-Hydroxylase Antibody (21-Ohab) | PCG | Class 2 | Immunology | No | 2022-12-15 |
| Antigen, Ebv, Capsid | MCD | Class 1 | Microbiology | No | 2022-12-16 |
| Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | NHX | Class 2 | Immunology | No | 2026-05-18 |
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 2022-12-13 |
| Legionella, Spp., Elisa | MJH | Class 2 | Microbiology | No | 2022-12-15 |
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2022-12-16 |
| Radioimmunoassay, Calcitonin | JKR | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Ige, Antigen, Antiserum, Control | DGC | Class 2 | Immunology | No | 2007-12-05 |
| Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | LJZ | Class 1 | Microbiology | No | 2022-12-15 |
| Antigen, B. Pertussis | GOX | Class 1 | Microbiology | No | 2022-12-14 |
| Radioimmunoassay, Estrone | CGF | Class 1 | Clinical Chemistry | No | 2022-12-13 |
| Reagent, Rickettsia Serological | LSQ | Class 1 | Microbiology | No | 2022-12-16 |
| Antibodies, Gliadin | MST | Class 2 | Immunology | No | 2022-12-16 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2022-12-14 |
| Retinol-Binding Protein, Antigen, Antiserum, Control | CZS | Class 1 | Immunology | No | 2022-12-14 |
| Immunochemical, Thyroglobulin Autoantibody | JNL | Class 2 | Immunology | No | 2022-12-16 |
| Radioimmunoassay, Total Thyroxine | CDX | Class 2 | Clinical Chemistry | No | 2022-12-13 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2022-12-15 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 1998-04-22 |
| Assay, Erythropoietin | GGT | Class 2 | Hematology | No | 2022-12-16 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2001-04-25 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2022-12-16 |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | MXJ | Class 2 | Microbiology | No | 2026-06-02 |
| Antigen, Agglutinating, Echinococcus Spp. | GPF | Class 1 | Microbiology | No | 2022-12-14 |
| Radioimmunoassay, Parathyroid Hormone | CEW | Class 2 | Clinical Chemistry | No | 2022-12-13 |
| Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | GNH | Class 1 | Microbiology | No | 2022-12-14 |
| Enzyme Linked Immunoabsorbent Assay, Mumps Virus | LJY | Class 1 | Microbiology | No | 2022-12-15 |
| Cryptosporidium Spp. | MHJ | Class 2 | Microbiology | No | 2022-12-16 |
| Antisera, Fluorescent, Adenovirus 1-33 | GNY | Class 1 | Microbiology | No | 2022-12-16 |
| Reagents, Cysticercosis | MDJ | Class 1 | Microbiology | No | 2022-12-16 |
| Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. | GMO | Class 2 | Microbiology | No | 2022-12-16 |
| Respiratory Syncytial Virus - Elisa | MCE | Class 1 | Microbiology | No | 2022-12-15 |
| Antigens, All, Leptospira Spp. | GRY | Class 2 | Microbiology | No | 2022-12-14 |
| Test System, Nicotine, Cotinine, Metabolites | MRS | Class 1 | Clinical Toxicology | No | 2022-12-16 |
| Radioimmunoassay, Acth | CKG | Class 2 | Clinical Chemistry | No | 2022-12-13 |
| Antigens, Cf (Including Cf Control), Adenovirus 1-33 | GOD | Class 1 | Microbiology | No | 2022-12-14 |
| Alpha-1 Microglobulin, Antigen, Antiserum, Control | MGA | Class 1 | Immunology | No | 2022-12-15 |
| Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | LJB | Class 1 | Microbiology | No | 2022-12-15 |
| Radioimmunoassay, Corticosterone | CHA | Class 1 | Clinical Chemistry | No | 2022-12-14 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 2022-12-14 |
| Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | KHW | Class 2 | Microbiology | No | 2022-12-15 |
| Giardia Spp. | MHI | Class 2 | Microbiology | No | 2022-12-16 |
| Radioimmunoassay, Pregnenolone | JNG | Class 1 | Clinical Chemistry | No | 2022-12-14 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2022-12-16 |
| Candida Species, Antibody Detection | LSG | Class 2 | Microbiology | No | 2022-12-15 |
Proprietary Names
Anti-Scl-70 ELISA
Lysozyme (Food) ELISA
ENA Screen ELISA, ENA-6-Profile ELISA
Total Thyroxine (tT4) ELISA
SALI-TUBES 500, SALI-TUBES 100
Lysozyme (stool) ELISA
PSA Total
TSH Receptor Autoantibody ELISA
Serotonin ELISA
Dengue Virus NS1 Ag ELISA
Triiodothyronine (T3) ELISA
AMTOX-DIP A-3 Jar
Amtox Grams Blank B-100
Amtox Control THc
Small Stand-off Jar THC-2
Amtox Discs Blank A-100
Toxi-Dip A-1 Small Stand-Off Jar
Amtox DIP B-1 Reagent Concentrate
Amtox Dip B-1-2-3 Reagent Concentrate
THC Developing Solution Bottle
AMTOX-DIP B-2 Jar
Multiple devopment rack with Chromatography Jar and Cap
Amtox Tubes B-100
Amtox Discs A
Amtox Grams Blank A-100
AMTOX-Dip THC-1 Reagent Jar
Microdispenser
Amtox Alum. Disp. Concentration Cups
Chromatography Jar with Cap
Amtox Dip A-2 Reagent Concentrate
AMTOX-DIP B-1 Jar
Amtox DIP B-3 Reagent Concentrate
Amtox DIP B-2 Reagent Concentrate
OMEGA-12+ Extraction Concentrator
Amtox DISCS A-1, Amtox Discs A-2, Amtox Discs A-3, Amtox DISCS A-4, Amtox Discs B-1 . Amtox Discs B-3 , Amtox Discs B-4
Amtox DIP A-3 Reagent Concentrate
Amtox Control 19
HCl Standoff THC-3 Jar
Amtox Discs Blank B-100
Small Stand-off Jar AMTOX-DIP A-1
AMTOX-DIP H2O Jar
Amtox Discs B-2
Amtox Tubes A-100
AMTOX-DIP A-2 Jar
Anti-dsDNA IgG ELISA, Anti-dsDNA IgM ELISA, Anti-dsDNA IgA ELISA, Anti-dsDNA Screen ELISA
TSH (ultrasensitive) ELISA
SHBG ELISA
Anti-Cardiolipin IgA ELISA
25 OH Vitamin D Total ELISA
Vitamin C (Ascorbic Acid)
Varicella Zoster Virus (VZV) IgG ELISA
Sperm Antibody ELISA, Sperm Antibody ELISA
West Nile Virus IgM (Flavivirus) ELISA
C-Reactive Protein HS ELISA
Human Growth Hormone (HGH) ELISA, TGF-?1 ELISA, TGF-?2 ELISA, HGH (Human Growth Hormone) ELISA, IGF-1 600 ELISA
Epstein Barr Virus VCA IgM ELISA
Histamine ELISA
FSH ELISA
Free Testosterone ELISA
Free Thyroxine (fT4) ELISA
Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA, Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA
T3-Uptake ELISA
De-Tox Tubes A-100, De-Tox Tubes B-100
CMV IgG ELISA
Androstenedione ELISA, Androstenedione (40 tests)
Prolactin ELISA, Prolactin
Anti-SS-A (Ro) ELISA
Anti-Thyroglobulin (Anti-Tg) ELISA
Cornybacterium diphtheriae toxin IgG ELISA
Trichinella spiralis IgG ELISA, Trichinella spiralis IgG ELISA, Strongyloides IgG ELISA,, Ascaris IgG ELISA
LuMate 4400 PC controlled Microplate Luminometer, DRG:HYBRiD.XL®
Myeloperoxidase IgG ELISA
Anti TPO Ab ELISA
Aspergillus fumigatus IgG ELISA
T3 Total ELISA
EIA-3517 Treponema Pallidum (Syphillis) IgG
EIA-4267 Treponema pallidum (Syphillis) IgM
C-Peptide ELISA, Insulin (human) Ultrasensitive ELISA
Thyroid Stimulating Hormone (TSH) ELISA
Beta-2 Microglobulin ELISA
Free Estriol ELISA, Free Estriol
p-ANCA (MPO) ELISA
Total Thyroxine (T4) ELISA
Progesterone (serum), Progesterone ELISA, Progesterone, Salivary Progesterone ELISA, Salivary Progesterone HS ELISA
Anti-Lactoferrin ELISA
Anti-Sm ELISA
Influenza Virus A IgG ELISA, Influenza Virus B IgG ELISA
EIA-1887 Cortisol
FSH ELISA, FSH
Free Triiodothyronine (fT3) ELISA, Total Triiodothyronine (tT3) ELISA, Free Triiodothyronine (fT3) ELISA
Micro-albumin ELISA
21-Hydroxylase Autoantibody ELISA
Epstein Barr Virus VCA IgG ELISA
EIA-5653 Anti-CCP.ELISA
Insulin ELISA, Anti-Insulin ELISA, Insulin
EBV-EBNA IgM ELISA
Anti-Jo-1 ELISA
Legionella pneumophila IgG ELISA
B. burgdorferi IgG/IgM ELISA
Calcitonin ELISA
Cardiolipin IgG ELISA
Testosterone ELISA
TPO IgG ELISA
Progesterone, 17-a-OH, 17 OH-Progesterone ELISA, Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA
Progesterone (17-a-OH Progesterone)
Borrelia burgdorferi IgG (Lyme) ELISA
Immunoglobulin E (IgE) ELISA
Mycoplasma pneumoniae IgG ELISA
Bordetella pertussis IgG ELISA, Bordetella pertussis Toxin (PT) IgG ELISA
Anti-Cardiolipin IgG/IgM ELISA
Estrone Serum, Estrone ELISA, Estrone ELISA
Rickettsia IgG ELISA
Gliadin IgA ELISA
Rheumatoid Factor Screen ELISA, RF IgG (Rheumatoid Factor) ELISA, Rheumatoid Factor IgM ELISA,
Rheumatoid Factor IgA ELISA
Salivary Testosterone ELISA
Cardiolipin IgA ELISA
DNA (ds) IgG ELISA
Retinol binding Protein (RBP)/RBP4 ELISA
Anti-Thyroid Peroxidase (Anti-TPO) ELISA
T-4 Total ELISA
Sample Preparation System (Stool)
LH-Serum ELISA, LH-Urine ELISA, LH ELISA, LH
Anti-Cardiolipin Screen ELISA
EPO (Erythropoietin) ELISA
Thyrotropin (TSH) ELISA, T3-Uptake ELISA, Thyrotropin (TSH) ELISA
Gliadin IgG ELISA
ENA-6-Profile ELISA, SSA (Ro) ELISA , Sm IgG ELISA, Sm RNP IgG ELISA, Sci-70 IgG ELISA, Jo-1 IgG ELISA
Estradiol (serum), Estradiol ELISA, Estradiol, Salivary Estradiol ELISA, Salivary Estradiol HS ELISA
Estradiol Sensitive ELISA
Multi Ligand Control
Anti-RNP/Sm ELISA
HSV-1 IgM ELISA
Echinococcus IgG ELISA
PTH (Parathyroid) Intact ELISA
Schistosoma IgG ELISA, Schistosoma mansoni IgG ELISA
Mumps Virus IgG ELISA
Cryptosporidium Antigen (stool) ELISA
c-ANCA (PR3) ELISA
Adenovirus Antigen (stool) ELISA
Taenia Solium IgG ELISA
EIA-3865 Toxocara canis IgG ELISA
Entamoeba histolytica Ag (stool) ELISA, Toxocara IgG ELISA
RF IgM (Rheumatoid Factor) ELISA
RSV IgG ELISA
Leptospira IgG ELISA, Leptospira IgG ELISA
Cotinine ELISA
ACTH (Adrenocorticotropic Hormone) ELISA
Adenovirus IgG ELISA
Salivary 17-OH Progesterone ELISA
Borrelia burgdorferi IgM (Lyme) ELISA
?1-Microglobulin ELISA
Anti-SS-B ELISA
Measles Virus IgG ELISA, Measles Virus IgG Avidity ELISA
Corticosterone ELISA
ANCA Screen IgG ELISA, Proteinase-3 IgG ELISA
ANA-8-Profile ELISA
ANA-8-Screen ELISA
ANA-8-Screen ELISA, ANA-8-Profile ELISA, ANA Detect ELISA
ANA Detect ELISA
DHEA-S, DHEA-S ELISA, DHEA ELISA, DHEA, DHEA-S
Anti TG Ab ELISA
ENA Screen (entractable nuclear antigen) ELISA
Entamoeba histolytica IgG ELISA, Entamoeba histolytica IgG ELISA
Giardia lamblia Antigen (stool) ELISA , Giardia/Cryptosporidium Ag (stool) ELISA
Pregnenolone Direct ELISA
ANA Screen IgG ELISA
Cardiolipin IgM ELISA
Crosslaps Serum ELISA
H. Pylori IgG ELISA
EBV-EA IgG ELISA
Candida albicans IgG ELISA
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device