Regulations research / FDA data / Establishments and listings / DHEA-S, DHEA-S ELISA, DHEA ELISA, DHEA, DHEA-S Establishments and listings DHEA-S, DHEA-S ELISA, DHEA ELISA, DHEA, DHEA-S DRG International, Inc. · Springfield, US
Repack or Relabel Medical Device +1 Reg. 2245285 JKC
Proprietary name DHEA-S, DHEA-S ELISA, DHEA ELISA, DHEA, DHEA-S
Establishment type Repack or Relabel Medical Device, Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 2245285
FEI number 2245285
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DRG International, Inc.
Address line 1 841 Mountain Ave
City Springfield
State code NJ
Iso country code US
Zip code 07081 Owner operator
Firm name BIOCHECK, INC.
Owner operator number 9033543 Official correspondent
First name Johanna
Middle initial -
Last name Saito
Phone number 1-650-5731968-x Contact address
Address 1 3451 Vincent Road
Address 2 --
City Pleasant Hill
State code CA
Iso country code US
Postal code 94523 Products
Product code JKC
Created date 2022-12-14
Owner operator number 9033543 Harmonized identifiers (openFDA)
Device name Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Medical specialty description Clinical Chemistry
Regulation number 862.1245
Device class 1 Establishments and listings Free Testosterone ELISA DRG International, Inc. · Springfield, US
Complaint File Establishment per 21 CFR 820.198 +1 Reg. 2245285 CDZ
K number K030730
Proprietary name Free Testosterone ELISA
Establishment type Complaint File Establishment per 21 CFR 820.198, Repack or Relabel Medical Device Registration
Registration number 2245285
FEI number 2245285
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DRG International, Inc.
Address line 1 841 Mountain Ave
City Springfield
State code NJ
Iso country code US
Zip code 07081 Owner operator
Firm name BIOCHECK, INC.
Owner operator number 9033543 Official correspondent
First name Johanna
Middle initial -
Last name Saito
Phone number 1-650-5731968-x Contact address
Address 1 3451 Vincent Road
Address 2 --
City Pleasant Hill
State code CA
Iso country code US
Postal code 94523 Products
Product code CDZ
Created date 2022-12-13
Owner operator number 9033543 Harmonized identifiers (openFDA)
Device name Radioimmunoassay, Testosterones And Dihydrotestosterone
Medical specialty description Clinical Chemistry
Regulation number 862.1680
Device class 1 Establishments and listings Aspergillus fumigatus IgG ELISA DRG International, Inc. · Springfield, US
Complaint File Establishment per 21 CFR 820.198 +1 Reg. 2245285 JWT
Proprietary name Aspergillus fumigatus IgG ELISA
Establishment type Complaint File Establishment per 21 CFR 820.198, Repack or Relabel Medical Device Registration
Registration number 2245285
FEI number 2245285
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DRG International, Inc.
Address line 1 841 Mountain Ave
City Springfield
State code NJ
Iso country code US
Zip code 07081 Owner operator
Firm name BIOCHECK, INC.
Owner operator number 9033543 Official correspondent
First name Johanna
Middle initial -
Last name Saito
Phone number 1-650-5731968-x Contact address
Address 1 3451 Vincent Road
Address 2 --
City Pleasant Hill
State code CA
Iso country code US
Postal code 94523 Products
Product code JWT
Created date 2022-12-15
Owner operator number 9033543 Harmonized identifiers (openFDA)
Device name Antigen, Cf, Aspergillus Spp.
Medical specialty description Microbiology
Regulation number 866.3040
Device class 1 Establishments and listings p-ANCA (MPO) ELISA DRG International, Inc. · Springfield, US
Repack or Relabel Medical Device +1 Reg. 2245285 MOB
K number K974701
Proprietary name p-ANCA (MPO) ELISA
Establishment type Repack or Relabel Medical Device, Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 2245285
FEI number 2245285
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DRG International, Inc.
Address line 1 841 Mountain Ave
City Springfield
State code NJ
Iso country code US
Zip code 07081 Owner operator
Firm name BIOCHECK, INC.
Owner operator number 9033543 Official correspondent
First name Johanna
Middle initial -
Last name Saito
Phone number 1-650-5731968-x Contact address
Address 1 3451 Vincent Road
Address 2 --
City Pleasant Hill
State code CA
Iso country code US
Postal code 94523 Products
Product code MOB
Created date 2022-12-15
Owner operator number 9033543 Harmonized identifiers (openFDA)
Device name Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Medical specialty description Immunology
Regulation number 866.5660
Device class 2 Establishments and listings Schistosoma IgG ELISA, Schistosoma mansoni IgG ELISA DRG International, Inc. · Springfield, US
Repack or Relabel Medical Device +1 Reg. 2245285 GNH
Proprietary name Schistosoma IgG ELISA, Schistosoma mansoni IgG ELISA
Establishment type Repack or Relabel Medical Device, Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 2245285
FEI number 2245285
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DRG International, Inc.
Address line 1 841 Mountain Ave
City Springfield
State code NJ
Iso country code US
Zip code 07081 Owner operator
Firm name BIOCHECK, INC.
Owner operator number 9033543 Official correspondent
First name Johanna
Middle initial -
Last name Saito
Phone number 1-650-5731968-x Contact address
Address 1 3451 Vincent Road
Address 2 --
City Pleasant Hill
State code CA
Iso country code US
Postal code 94523 Products
Product code GNH
Created date 2022-12-14
Owner operator number 9033543 Harmonized identifiers (openFDA)
Device name Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
Medical specialty description Microbiology
Regulation number 866.3600
Device class 1 Establishments and listings EIA-2111 Helicobacter pylori IgM ELISA DRG International, Inc. · Springfield, US
Repack or Relabel Medical Device +1 Reg. 2245285 LYR
Proprietary name EIA-2111 Helicobacter pylori IgM ELISA
Establishment type Repack or Relabel Medical Device, Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 2245285
FEI number 2245285
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DRG International, Inc.
Address line 1 841 Mountain Ave
City Springfield
State code NJ
Iso country code US
Zip code 07081 Owner operator
Firm name BIOCHECK, INC.
Owner operator number 9033543 Official correspondent
First name Johanna
Middle initial -
Last name Saito
Phone number 1-650-5731968-x Contact address
Address 1 3451 Vincent Road
Address 2 --
City Pleasant Hill
State code CA
Iso country code US
Postal code 94523 Products
Product code LYR
Created date 2026-09-01
Owner operator number 9033543 Harmonized identifiers (openFDA)
Device name Helicobacter Pylori
Medical specialty description Microbiology
Regulation number 866.3110
Device class 1 Establishments and listings ENA Screen ELISA, ENA-6-Profile ELISA DRG International, Inc. · Springfield, US
Complaint File Establishment per 21 CFR 820.198 +1 Reg. 2245285 LLL
K number K955134
Proprietary name ENA Screen ELISA, ENA-6-Profile ELISA
Establishment type Complaint File Establishment per 21 CFR 820.198, Repack or Relabel Medical Device Registration
Registration number 2245285
FEI number 2245285
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DRG International, Inc.
Address line 1 841 Mountain Ave
City Springfield
State code NJ
Iso country code US
Zip code 07081 Owner operator
Firm name BIOCHECK, INC.
Owner operator number 9033543 Official correspondent
First name Johanna
Middle initial -
Last name Saito
Phone number 1-650-5731968-x Contact address
Address 1 3451 Vincent Road
Address 2 --
City Pleasant Hill
State code CA
Iso country code US
Postal code 94523 Products
Product code LLL
Created date 2022-12-15
Owner operator number 9033543 Harmonized identifiers (openFDA)
Device name Extractable Antinuclear Antibody, Antigen And Control
Medical specialty description Immunology
Regulation number 866.5100
Device class 2 Establishments and listings Calcitonin ELISA DRG International, Inc. · Springfield, US
Complaint File Establishment per 21 CFR 820.198 +1 Reg. 2245285 JKR
K number K982491
Proprietary name Calcitonin ELISA
Establishment type Complaint File Establishment per 21 CFR 820.198, Repack or Relabel Medical Device Registration
Registration number 2245285
FEI number 2245285
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DRG International, Inc.
Address line 1 841 Mountain Ave
City Springfield
State code NJ
Iso country code US
Zip code 07081 Owner operator
Firm name BIOCHECK, INC.
Owner operator number 9033543 Official correspondent
First name Johanna
Middle initial -
Last name Saito
Phone number 1-650-5731968-x Contact address
Address 1 3451 Vincent Road
Address 2 --
City Pleasant Hill
State code CA
Iso country code US
Postal code 94523 Products
Product code JKR
Created date 2022-12-15
Owner operator number 9033543 Harmonized identifiers (openFDA)
Device name Radioimmunoassay, Calcitonin
Medical specialty description Clinical Chemistry
Regulation number 862.1140
Device class 2 Establishments and listings T3 Total ELISA DRG International, Inc. · Springfield, US
Repack or Relabel Medical Device +1 Reg. 2245285 CDP
Proprietary name T3 Total ELISA
Establishment type Repack or Relabel Medical Device, Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 2245285
FEI number 2245285
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DRG International, Inc.
Address line 1 841 Mountain Ave
City Springfield
State code NJ
Iso country code US
Zip code 07081 Owner operator
Firm name BIOCHECK, INC.
Owner operator number 9033543 Official correspondent
First name Johanna
Middle initial -
Last name Saito
Phone number 1-650-5731968-x Contact address
Address 1 3451 Vincent Road
Address 2 --
City Pleasant Hill
State code CA
Iso country code US
Postal code 94523 Products
Product code CDP
Created date 1998-04-22
Owner operator number 9033543 Harmonized identifiers (openFDA)
Device name Radioimmunoassay, Total Triiodothyronine
Medical specialty description Clinical Chemistry
Regulation number 862.1710
Device class 2 Establishments and listings Mumps Virus IgG ELISA DRG International, Inc. · Springfield, US
Repack or Relabel Medical Device +1 Reg. 2245285 LJY
Proprietary name Mumps Virus IgG ELISA
Establishment type Repack or Relabel Medical Device, Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 2245285
FEI number 2245285
Status code 1
Initial importer flag Y
Reg expiry date year 2026
Name DRG International, Inc.
Address line 1 841 Mountain Ave
City Springfield
State code NJ
Iso country code US
Zip code 07081 Owner operator
Firm name BIOCHECK, INC.
Owner operator number 9033543 Official correspondent
First name Johanna
Middle initial -
Last name Saito
Phone number 1-650-5731968-x Contact address
Address 1 3451 Vincent Road
Address 2 --
City Pleasant Hill
State code CA
Iso country code US
Postal code 94523 Products
Product code LJY
Created date 2022-12-15
Owner operator number 9033543 Harmonized identifiers (openFDA)
Device name Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Medical specialty description Microbiology
Regulation number 866.3380
Device class 1 142 records share this identifier (an establishment lists each device separately); the first 10 are shown.
Wholesale access for licensed clinicians. Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.
Data from openFDA , FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.
