FDA UDI
In Commercial Distribution
🇺🇸 United States
ARCHITECT
DI: 00380740119409
·
Model: 2K98-11
·
Abbott GmbH
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ARCHITECT
- Primary DI
- 00380740119409
- Version / Model
- 2K98-11
- Catalog Number
- 02K9811
- Company Name
- Abbott GmbH
- Labeler DUNS
- 315786293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-31
- Public Version
- 5
- Public Version Date
- 2024-08-06
- Public Version Status
- Update
- Public Device Record Key
- 8ad9be8d-8179-4616-94fe-b326647b9218
Device Description
Microalbumin Controls
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
- No
- 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 |
|---|---|---|---|---|
| JIQ | TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1645 | 1 |
| JJX | Single (specified) analyte controls (assayed and unassayed) | Clinical Chemistry | 862.1660 | 1 |
| JIS | CALIBRATOR, PRIMARY | Clinical Chemistry | 862.1150 | 2 |
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 | 00380740119409 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze controls.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 1 – 29 Degrees Celsius