FDA UDI
In Commercial Distribution
🇺🇸 United States
Alere Afinion ACR Control
DI: 07070060006765
·
Model: 1115239
·
Abbott Diagnostics Technologies AS
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Alere Afinion ACR Control
- Primary DI
- 07070060006765
- Version / Model
- 1115239
- Catalog Number
- 1115239
- Company Name
- Abbott Diagnostics Technologies AS
- Labeler DUNS
- 515324122
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-07
- Public Version
- 3
- Public Version Date
- 2019-05-09
- Public Version Status
- Update
- Public Device Record Key
- 92fff2da-1308-452c-94f7-415ab56c9814
Device Description
ACR Control for use with the Alere Afinion ACR test and Afinion ACR test. Contents: 1 Control C I, 1 Control C II, 1 package insert. DI covers Alere Afinion ACR Control and and Afinion ACR Control.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53478 | Microalbumin IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of microalbumin in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07070060006765 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 46 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius