Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2245285

FEI Number

2245285

Entity Name

DRG International, Inc.

City/State/Country

Springfield, NJ, US

Establishment Address

841 Mountain Ave, Springfield, NJ 07081, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

BIOCHECK, INC. (Owner Number: 9033543)

Owner / Operator Contact Address

3451 Vincent Road, --, Pleasant Hill, CA 94523, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K974702

PMA Number

N/A

All Registered 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 Free Thyroxine (fT4) ELISA Anti-Sm ELISA Free Testosterone 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 Anti-Lactoferrin 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2022-12-15
JMR	Immunochemical, Lysozyme (Muramidase)	Clinical Chemistry	Class 1	862.1490	2022-12-15
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2022-12-15
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2022-12-16
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2022-12-15
JMQ	M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)	Clinical Chemistry	Class 1	862.1490	2022-12-15
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2026-05-11
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2022-12-15
CDA	Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin	Clinical Chemistry	Class 1	862.1390	2023-05-03
QCU	Dengue Virus Antigen Assay	Microbiology	Class 2	866.3945	2023-03-22
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2007-12-05
KZS	Chromatography (Thin Layer), Clinical Use	Clinical Chemistry	Class 1	862.2270	2022-12-16
LRM	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	Immunology	Class 2	866.5100	2022-12-15
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2007-12-05
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2026-05-11
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2022-12-15
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2022-12-15
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2022-12-15
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Microbiology	Class 2	866.3900	2022-12-16
DFQ	Sperm, Antigen, Antiserum, Control	Immunology	Class 1	866.5800	2022-12-14
NOP	Elisa, Antibody, West Nile Virus	Microbiology	Class 2	866.3940	2022-12-15
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2007-12-05
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	1998-04-22
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2022-12-16
IAF	Wright'S Stain	Hematology	Class 1	864.1850	2022-12-14
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2022-12-13
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2022-12-13
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2022-12-13
GPR	Antiserum, Cf, Q Fever	Microbiology	Class 1	866.3500	2022-12-14
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2022-12-19
DPA	Apparatus, General Use, Thin Layer Chromatography	Clinical Chemistry	Class 1	862.2270	2022-12-16
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2022-12-16
CIZ	Radioimmunoassay, Androstenedione	Clinical Chemistry	Class 1	862.1075	2022-12-14
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	1998-04-22
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2022-12-15
DDC	Thyroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5870	2022-12-15
GOS	Antiserum, Fluorescent, C. Diphtheriae	Microbiology	Class 1	866.3140	2022-12-14
MDT	Elisa, Trichinella Spiralis	Microbiology	Class 1	866.3850	2022-12-15
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2022-12-12
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2022-12-16
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2022-12-15
JWT	Antigen, Cf, Aspergillus Spp.	Microbiology	Class 1	866.3040	2022-12-15
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	1998-04-22
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2026-06-15
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2022-12-15
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2007-12-05
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2007-12-05
CGI	Radioimmunoassay, Estriol	Clinical Chemistry	Class 1	862.1265	2022-12-14
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2022-12-15
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2007-12-05
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2001-04-25
DEG	Lactoferrin, Antigen, Antiserum, Control	Immunology	Class 1	866.5570	2022-12-14
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2022-12-16
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2022-12-15
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2022-12-13
GNW	Antisera, Cf, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2022-12-14
CGR	Radioimmunoassay, Cortisol	Clinical Chemistry	Class 2	862.1205	2026-05-18
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	1998-04-22
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2022-12-13
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2022-12-15
PCG	21-Hydroxylase Antibody (21-Ohab)	Immunology	Class 2	866.5660	2022-12-15
MCD	Antigen, Ebv, Capsid	Microbiology	Class 1	866.3235	2022-12-16
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2026-05-18
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2022-12-13
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2026-04-24
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2022-12-15
MJH	Legionella, Spp., Elisa	Microbiology	Class 2	866.3300	2022-12-15
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2022-12-16
JKR	Radioimmunoassay, Calcitonin	Clinical Chemistry	Class 2	862.1140	2022-12-15
DEG	Lactoferrin, Antigen, Antiserum, Control	Immunology	Class 1	866.5570	2022-12-14
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2022-12-16
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2022-12-12
DDC	Thyroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5870	2022-12-15
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	Class 1	862.1395	2022-12-15
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2022-12-16
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-05
LJZ	Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.	Microbiology	Class 1	866.3375	2022-12-15
GOX	Antigen, B. Pertussis	Microbiology	Class 1	866.3065	2022-12-14
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2022-12-15
CGF	Radioimmunoassay, Estrone	Clinical Chemistry	Class 1	862.1280	2022-12-13
LSQ	Reagent, Rickettsia Serological	Microbiology	Class 1	866.3500	2022-12-16
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2022-12-16
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2022-12-14
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2022-12-13
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2022-12-16
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2022-12-16
CZS	Retinol-Binding Protein, Antigen, Antiserum, Control	Immunology	Class 1	866.5765	2022-12-14
JNL	Immunochemical, Thyroglobulin Autoantibody	Immunology	Class 2	866.5870	2022-12-16
CDX	Radioimmunoassay, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2022-12-13
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2022-12-15
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	1998-04-22
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2022-12-15
GGT	Assay, Erythropoietin	Hematology	Class 2	864.7250	2022-12-16
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2022-12-16
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2022-12-16
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2022-12-16
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2001-04-25
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2022-12-16
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2022-12-15
MXJ	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	Microbiology	Class 2	866.3305	2026-06-02
GPF	Antigen, Agglutinating, Echinococcus Spp.	Microbiology	Class 1	866.3200	2022-12-14
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2022-12-13
GNH	Antigen, Fluorescent Antibody Test, Schistosoma Mansoni	Microbiology	Class 1	866.3600	2022-12-14
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Microbiology	Class 1	866.3380	2022-12-15
MHJ	Cryptosporidium Spp.	Microbiology	Class 2	866.3220	2022-12-16
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2022-12-15

Official Correspondent

Johanna Saito

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOCHECK, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2953756	BIOCHECK, INC.	Pleasant Hill, CA, US
3002800697	DRG INSTRUMENTS GMBH	MARBURG Hesse, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K941042	Microgenics Corp.	CEDIA T4 MAB ASSAY	1994-04-26
K082638	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL	2009-02-26
K000362	Zeus Scientific, Inc.	MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM	2000-02-18
K250250	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Anti-Thyroid Peroxidase II	2025-10-17
K152061	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material	2016-03-03

Related Recall Records

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Z-0022-2025	Qualigen Inc	2	FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0044-2020	Roche Diagnostics Operations, Inc.	2	AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Z-0072-2017	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Centaur XPT Immunoassay System
Z-0034-2008	Louisville Apl Diagnostics Inc	2	APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).
Z-0032-2026	Beckman Coulter Inc.	2	DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2245285. Last updated year: 2026. Please use registration number 2245285 when referencing this establishment in official correspondence.