FDA UDI
In Commercial Distribution
🇺🇸 United States
ARCHITECT
DI: 00380740156855
·
Model: 2J94-22
·
ABBOTT LABORATORIES
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARCHITECT
- Primary DI
- 00380740156855
- Version / Model
- 2J94-22
- Catalog Number
- 02J9422
- Company Name
- ABBOTT LABORATORIES
- Labeler DUNS
- 117245596
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-31
- Public Version
- 5
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- 79f051f0-661a-470a-9ba9-a29395cdb2ef
Device Description
Detergent B
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 |
|---|---|---|---|---|
| CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE | Clinical Chemistry | 862.1170 | 2 |
| JGS | ELECTRODE, ION SPECIFIC, SODIUM | Clinical Chemistry | 862.1665 | 2 |
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM | Clinical Chemistry | 862.1600 | 2 |
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | Clinical Chemistry | 862.2160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56676 | Multiple clinical chemistry analyser IVD, laboratory | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (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 | 00380740156855 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius