FDA UDI
In Commercial Distribution
🇺🇸 United States
Afinion ACR
DI: 07070060014630
·
Model: 1116972
·
Abbott Diagnostics Technologies AS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Afinion ACR
- Primary DI
- 07070060014630
- Version / Model
- 1116972
- Catalog Number
- 1116972
- Company Name
- Abbott Diagnostics Technologies AS
- Labeler DUNS
- 515324122
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-16
- Public Version
- 2
- Public Version Date
- 2022-11-07
- Public Version Status
- Update
- Public Device Record Key
- d3e50eb5-2f47-4e28-b247-513e701f9b11
Device Description
Albumin/Creatinine ration test kit. Intended use: For the determination of albumin, creatinine and albumin/creatinine ration in human urine. Contetns: 15 test cartridges. 1 package insert.
Device Characteristics
- Single Use
- Yes
- 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
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JFY | Enzymatic Method, Creatinine | Clinical Chemistry | 862.1225 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53479 | Microalbumin IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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 | 07070060014630 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius