ARCHITECT
- Primary DI
- 00380740000202
- Brand
- ARCHITECT
- Company
- ABBOTT LABORATORIES
- Model
- 1E01-21
- Catalog number
- 01E0121
- Device description
- Immunoglobulin M
- Published
- 2016-06-06
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
xx.xxProduct Codes#
| Code | Name |
|---|---|
| DFT | IGM, ANTIGEN, ANTISERUM, CONTROL |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DFT | Igm, Antigen, Antiserum, Control | Immunology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00380740000202 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00380740000202 | 00380740000202 | 380740000202 | 0380740000202 |
GMDN Terms#
| Term | Definition |
|---|---|
| Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin M (IgM total) in a clinical specimen, using a nephelometry/turbidimetry method. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Temperature | 0 | 29 Degrees Celsius | |
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(877)422-2688 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 079226220
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00380740153694 | Alinity | 01R1302 | 01R1302 | 2023-10-14 |
| 00380740153762 | Alinity | 04R4612 | 04R4612 | 2023-10-14 |
| 00380740156305 | ARCHITECT | 06K4604 | 06K4604 | 2020-03-03 |
| 00380740156381 | ARCHITECT | 06K5422 | 06K5422 | 2020-03-03 |
| 00380740156398 | ARCHITECT | 06K5523 | 06K5523 | 2020-03-03 |
| 00380740030056 | ARCHITECT | 6K46-02 | 06K4602 | 2018-07-31 |
| 00380740044831 | ARCHITECT | 6K54-21 | 06K5421 | 2018-07-31 |
| 00380740045593 | ARCHITECT | 6K55-22 | 06K5522 | 2018-07-31 |
| 00380740202798 | Alinity | 04W5607 | 04W5607 | 2025-07-21 |
| 00380740203108 | Alinity | 04W5615 | 04W5615 | 2025-07-21 |
| 00380740203115 | Alinity | 04W5625 | 04W5625 | 2025-07-21 |
| 00380740203139 | Alinity | 04W5661 | 04W5661 | 2025-07-21 |
| 00380740192402 | CELL-DYN | 09H6003 | 09H6003 | 2020-12-18 |
| 00380740020132 | CELL-DYN | 09H46-02 | 09H4602 | 2016-06-06 |
| 00380740020149 | CELL-DYN | 09H47-02 | 09H4702 | 2016-06-06 |
| 00380740020156 | CELL-DYN | 09H48-02 | 09H4802 | 2016-06-06 |
| 00380740120771 | CELL-DYN | 09H6101 | 09H6101 | 2016-09-09 |
| 00380740120788 | CELL-DYN | 09H62-01 | 09H6201 | 2016-09-09 |
| 00380740202668 | Alinity | 06P0107 | 06P0107 | 2025-10-03 |
| 00380740202828 | Alinity | 06P0115 | 06P0115 | 2025-10-03 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00380740169916 | Alinity | ABBOTT IRELAND | DFT | 2021-04-29 |
| 00380740169923 | ARCHITECT | ABBOTT IRELAND | DFT | 2021-04-02 |
| 00380740175115 | ARCHITECT | Abbott GmbH | DFT | 2020-11-06 |
| 03610230007365 | Yumizen C1200 Immunoglobulin M | HORIBA ABX SAS | DFT | 2020-07-13 |
| 00380740150693 | Alinity | Abbott GmbH | DFT | 2019-07-08 |
| 05055273204001 | IgM | RANDOX LABORATORIES LIMITED | DFT | 2016-09-24 |
| 05055273204025 | IgM | RANDOX LABORATORIES LIMITED | DFT | 2016-09-24 |
| M52594000 | ImmunoFix Controls | HELENA LABORATORIES CORPORATION | DFT | 2016-09-07 |