FDA UDI
In Commercial Distribution
🇺🇸 United States
ARCHITECT
DI: 00380740156367
·
Model: 06K5004
·
ABBOTT LABORATORIES
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ARCHITECT
- Primary DI
- 00380740156367
- Version / Model
- 06K5004
- Catalog Number
- 06K5004
- Company Name
- ABBOTT LABORATORIES
- Labeler DUNS
- 079226220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-03
- Public Version
- 2
- Public Version Date
- 2023-08-25
- Public Version Status
- Update
- Public Device Record Key
- bcfc4203-abb4-43bf-a46e-9e8aa0a6c1d6
Device Description
Quantia IgE Calibrators
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 |
|---|---|---|---|---|
| JJS | Controls for blood-gases, (assayed and unassayed) | Clinical Chemistry | 862.1660 | 1 |
| JJX | Single (specified) analyte controls (assayed and unassayed) | Clinical Chemistry | 862.1660 | 1 |
| DGC | IGE, ANTIGEN, ANTISERUM, CONTROL | Immunology | 866.5510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53777 | Total immunoglobulin E (IgE total) IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of total immunoglobulin E (IgE total) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380740156367 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K050493 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- High: 29 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius