FDA UDI
In Commercial Distribution
🇺🇸 United States
ARCHITECT
DI: 00380740011161
·
Model: 6L27-01
·
Abbott GmbH
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARCHITECT
- Primary DI
- 00380740011161
- Version / Model
- 6L27-01
- Catalog Number
- 06L2701
- Company Name
- Abbott GmbH
- Labeler DUNS
- 315786293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 5
- Public Version Date
- 2024-02-21
- Public Version Status
- Update
- Public Device Record Key
- 5aa7514d-546b-4567-8f63-edd232010975
Device Description
ARCHITECT HAVAB-G Calibrator
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 |
|---|---|---|---|---|
| JIS | CALIBRATOR, PRIMARY | Clinical Chemistry | 862.1150 | 2 |
| LOL | Hepatitis a test (antibody and igm antibody) | Microbiology | 866.3310 | 2 |
| MJX | KIT, SEROLOGICAL, POSITIVE CONTROL | Clinical Chemistry | 862.1660 | 1 |
| MJY | KIT, SEROLOGICAL, NEGATIVE CONTROL | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41957 | Hepatitis A virus immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to the Hepatitis A virus in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380740011161 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113704 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius