FDA UDI
In Commercial Distribution
🇺🇸 United States
BioCode 2500 Multiplex Detection System
DI: 00851034007059
·
Model: 1
·
APPLIED BIOCODE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioCode 2500 Multiplex Detection System
- Primary DI
- 00851034007059
- Version / Model
- 1
- Catalog Number
- 41-A0005
- Company Name
- APPLIED BIOCODE, INC.
- Labeler DUNS
- 004580003
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-22
- Public Version
- 1
- Public Version Date
- 2018-09-24
- Public Version Status
- New
- Public Device Record Key
- de484c86-b8b1-4451-959b-fd332a5ef95d
Device Description
The BioCode 2500 Multiplex Detection System is a digital optics imaging system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) technology.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | Clinical Chemistry | 862.2300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57864 | Microplate reader IVD, semi-automated | A mains electricity (AC-powered) laboratory instrument intended to be used to photometrically measure the optical absorbance or emission of clinical specimens in microplates containing multiple individual sample wells, with or without a separate cuvette-reading station. The device utilizes technology which may include reagent dispensing, a single or dual lightsource, bandpass filters, monochromators, photodetectors, data processing software and/or data displays to determine the qualitative and/or quantitative values of biological constituents of a clinical specimen. The device operates with reduced technician involvement and automation of some, but not all, procedural steps. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851034007059 | GS1 |
Customer Contacts
- Phone
- 5628010050
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius