FDA UDI
In Commercial Distribution
🇺🇸 United States
Afinion™ 2
DI: 07070060014623
·
Model: 1116971
·
Abbott Diagnostics Technologies AS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Afinion™ 2
- Primary DI
- 07070060014623
- Version / Model
- 1116971
- Catalog Number
- 1116971
- Company Name
- Abbott Diagnostics Technologies AS
- Labeler DUNS
- 515324122
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-26
- Public Version
- 1
- Public Version Date
- 2023-11-03
- Public Version Status
- New
- Public Device Record Key
- b6732953-814a-441c-92cd-0a37770450ea
Device Description
Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient testing and laboratory use. Afinion 2 is designed for use with the Afinion Test Cartridges only. The Afinion 2 System, consisting of Afinion 2 Analyzer with Afinion Test Cartridges and Afinion Controls, is intended for in vitro diagnostic use only. Contents: 1 Afinion 2 Analyzer
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | Clinical Chemistry | 862.2400 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62181 | Multiple clinical chemistry analyser IVD, point-of-care | A portable, electrically-powered instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technology(ies) [e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence]. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07070060014623 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 32 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -29 – 60 Degrees Celsius