FDA UDI
In Commercial Distribution
🇺🇸 United States
ARCHITECT
DI: 00380740002138
·
Model: 1P74-27
·
ABBOTT IRELAND
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ARCHITECT
- Primary DI
- 00380740002138
- Version / Model
- 1P74-27
- Catalog Number
- 01P7427
- Company Name
- ABBOTT IRELAND
- Labeler DUNS
- 989964119
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 4
- Public Version Date
- 2024-02-21
- Public Version Status
- Update
- Public Device Record Key
- 0d6c4fe8-8b90-4ee9-a013-6fb584d93ca8
Device Description
ARCHITECT Folate Reagent Kit (100T)
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 |
|---|---|---|---|---|
| JIT | CALIBRATOR, SECONDARY | Clinical Chemistry | 862.1150 | 2 |
| JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | Clinical Chemistry | 862.1660 | 1 |
| CGN | ACID, FOLIC, RADIOIMMUNOASSAY | Clinical Chemistry | 862.1295 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54455 | Folate (vitamin B9) 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 qualitative and/or quantitative detection of folate (vitamin B9) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380740002138 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius