FDA UDI
In Commercial Distribution
🇺🇸 United States
BioArray Assay Imaging System TM (AIS) 400C
DI: 10888234102212
·
Model: 790-20006-RF
·
BIOARRAY SOLUTIONS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioArray Assay Imaging System TM (AIS) 400C
- Primary DI
- 10888234102212
- Version / Model
- 790-20006-RF
- Catalog Number
- 790-20006-RF
- Company Name
- BIOARRAY SOLUTIONS LTD
- Labeler DUNS
- 949103725
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-28
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7db432e8-6c45-4d36-a7c7-d16bf1b99460
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57852 | Microarray analyser IVD, semi-automated | A mains electricity (AC-powered) laboratory instrument intended to be used for the in vitro determination of multiple target analytes in a single clinical specimen using oligonucleotide capture molecules arranged in a consistent pattern on a slide, chip or membrane. Identification of a target sequence in the clinical specimen is by hybridization of complementary base pairs, with a detection system typically using fluorophores, fluorescent-labelled dyes, and/or digital imaging techniques. 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 | 10888234102212 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK130051 | 0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid exposure to direct sunlight
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Temperature of 15 degrees Celsius to 26.7 degrees Celsius when in use