FDA Registration
Active
🇺🇸 United States
Amtox discs B-2, TDS-6139
Reg #: 2245285
·
FEI: 2245285
·
Expires 2025
Products
1
Proprietary Names
41
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DRG International, Inc.
- Registration Number
- 2245285
- FEI Number
- 2245285
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 841 Mountain Ave
- City
- Springfield
- State
- NJ
- ZIP
- 07081
- Country
- US
Owner / Operator
- Firm Name
- BIOCHECK, INC.
- Operator Number
- 9033543
- Address
- 425 Eccles Avenue, --
- City
- South San Francisco
- State
- CA
- Postal Code
- 94080
- Country
- US
- Correspondent
- Johanna - Saito
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chromatography (Thin Layer), Clinical Use | KZS | Class 1 | Clinical Chemistry | No | 2022-12-16 |
Proprietary Names
Amtox discs B-2, TDS-6139
Amtox Discs A-2 (50 discs per pack), TDS-0789
Amtox DIP B-1 reagent concentrate, TDS-1036
Amtox Discs B-3, TDS-0785
Amtox DISCS A-1-100, TDS-0780
Amtox discs blank B-100, TDS-0871
Amtox aluminum disposable concentration cups, TDS-0790
Amtox Discs B-1, TDS-0784
Amtox DISCS B-4, TDS-0786
AMTOX-Dip A-2 Reagent Concentrate, TDS-5789
Amtox DIP B-3 Reagent concentrate, TDS-1038
Amtox DIP B-2 Reagent concentrate, TDS-1037
Amtox Control 19 (50 ml bottle), TDS-0787
Amtox Tubes B-100, TDS-0873
OMEGA-12+Extraction Concentrator, TDS-0791
Amtox Dip B-1-2-3 Reagent concentrate, TDS-6140
AMTOX-Dip A-3 Jar, TDS-0878
Amtox Grams Blank A-100, TDS-1041
Amtox DIP A-3 Reagent concentrate, TDS-0823
Amtox Dip A-2 Reagent Concentrate (1 vial per pack), TDS-5789
Amtox tubes A-100, TDS-0872
Microdispenser, TDS-0865
Toxi-Dip A-1 Small Stand-Off Jar, TDS-0829
AMTOX-Dip H2O Jar, TDS-0877
AMTOX HCl Stand-off THC-3 Jar, TDS-1085
Amtox discs blank A-100, TDS-0870
Amtox Discs A-4, TDS-0783
Amtox Control THC, TDS-0908
Amtox Discs A Custom Order, TDS-5790
Amtox Grams Blank B-100, TDS-1042
AMTOX-Dip B-1 Jar, TDS-0879
Amtox Discs A-2, TDS-0781
AMTOX-Dip A-2 Jar, TDS-0881
Chromatography Jar with Cap, TDS-0827
Small Stand-off Jar THC-2, TDS-0817
AMTOX-Dip THC-1 Reagent jar, TDS-0815
Multiple development rack with Chromatography Jar and Cap, TDS-0828
Amtox-Dip A-1 Stand-off Jar, TDS-0876
Amtox Discs A-3, TDS-0782
AMTOX Discs A, TDS-5790
AMTOX-Dip B-2 Jar, TDS-0880
Establishment Types
Repack or Relabel Medical Device