| Primary Device ID | 00851034007042 |
| NIH Device Record Key | 46d5c808-17b6-48e8-9e84-0e8705e320e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioCode SA-PE Mix Pack |
| Version Model Number | 1 |
| Company DUNS | 004580003 |
| Company Name | APPLIED BIOCODE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 562-801-0050 |
| tpham@apbiocode.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851034007042 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-07 |
| Device Publish Date | 2019-07-30 |
| 00851034007073 - BioCode Respiratory Pathogen Panel | 2020-01-20 In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens. |
| 00851034007028 - BioCode MDx 3000 Optical Calibration and Verification Kit | 2019-08-07 Kit containing calibrators and controls for MDx 3000. |
| 00851034007035 - BioCode MDx 3000 Buffer A | 2019-08-07 Buffer used in MDx 3000 assays. |
| 00851034007042 - BioCode SA-PE Mix Pack | 2019-08-07Fluorescence dye for MDx 3000 assays. |
| 00851034007042 - BioCode SA-PE Mix Pack | 2019-08-07 Fluorescence dye for MDx 3000 assays. |
| 00851034007004 - BioCode MDx 3000 | 2018-11-15 The BioCode MDx 3000 is an automated molecular diagnostic system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) |
| 00851034007011 - Gastrointestinal Pathogen Panel (GPP) Kit | 2018-11-15 In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens. |
| 00851034007059 - BioCode 2500 Multiplex Detection System | 2018-09-24 The BioCode 2500 Multiplex Detection System is a digital optics imaging system for use with Applied BioCode’s Barcoded Magneti |