apbiocode.comBioCode Gastrointestinal Pathogen Panel (GPP)
Applied BioCode, Inc.
Applied BioCode, Inc.
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007799234 | 3007799234 | Applied BioCode, Inc. | 1 | N | 2026-01-01 | 12130 Mora Drive Unit #2 Santa Fe Springs CA US 90670 |
GUDID Contact Samples
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00851034007004 | BioCode MDx 3000 - The BioCode MDx 3000 is an automated molecular diagnostic system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) assays. | 5628010050 | tpham@apbiocode.com |
| 00851034007011 | Gastrointestinal Pathogen Panel (GPP) Kit - In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens. | 562-801-0050 | tpham@apbiocode.com |
| 00851034007035 | BioCode MDx 3000 Buffer A - Buffer used in MDx 3000 assays. | 562-801-0050 | tpham@apbiocode.com |
| 00851034007042 | BioCode SA-PE Mix Pack - Fluorescence dye for MDx 3000 assays. | 562-801-0050 | tpham@apbiocode.com |
| 00851034007059 | BioCode 2500 Multiplex Detection System - The BioCode 2500 Multiplex Detection System is a digital optics imaging system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) technology. | 5628010050 | tpham@apbiocode.com |
| 00851034007073 | BioCode Respiratory Pathogen Panel - In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens. | 8332462633 | atang@apbiocode.com |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 102511 | 1471836833 | K192485 | BioCode Respiratory Pathogen Panel (RPP) | OCC | 2019-12-23 |
| 102511 | 1440475908 | K190585 | Biocode Gastrointestinal Pathogen Panel (GPP) | PCH | 2019-06-05 |
| 102511 | 1382057131 | K180041 | BioCode Gastrointestinal Pathogen Panel (GPP) | PCH | 2018-09-28 |
| 102511 | 1093225513 | ||||
| 102511 | 1475300462 | ||||
| 102511 | 1481900259 | ||||
| 102511 | 1559458757 | ||||
| 102511 | 1791370558 |
Product Codes Associated With Registrations
PMN
BioCode Respiratory Pathogen Panel (RPP)
Applied BioCode, Inc.
Biocode Gastrointestinal Pathogen Panel (GPP)
Applied Biocode, Inc.
BioCode Gastrointestinal Pathogen Panel (GPP)
Applied Biocode, Inc.
GUDID
BioCode Respiratory Pathogen Panel - In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens.
2020-01-10
BioCode MDx 3000 Optical Calibration and Verification Kit - Kit containing calibrators and controls for MDx 3000.
2019-07-30
BioCode MDx 3000 Buffer A - Buffer used in MDx 3000 assays.
2019-07-30
BioCode SA-PE Mix Pack - Fluorescence dye for MDx 3000 assays.
2019-07-30
BioCode MDx 3000 - The BioCode MDx 3000 is an automated molecular diagnostic system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) assays.
2018-10-15
Gastrointestinal Pathogen Panel (GPP) Kit - In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
2018-10-15
BioCode 2500 Multiplex Detection System - The BioCode 2500 Multiplex Detection System is a digital optics imaging system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) technology.
2018-08-22