ORTHO
- Primary DI
- 10758750007462
- Brand
- ORTHO
- Company
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Model
- 6901968
- Catalog number
- 6901968
- Device description
- T.CRUZI ELISA Test System 480T
- Published
- 2014-10-22
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10758750007462 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10758750007462 | 10758750007462 |
GMDN Terms#
| Term | Definition |
|---|---|
| Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to the parasitic protozoan Trypanosoma cruzi in a clinical specimen, using an enzyme immunoassay (EIA) method. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 068715424
- 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 |
|---|---|---|---|---|
| 10758750000340 | VITROS | 1943927 | 1943927 | 2020-05-16 |
| 10758750012824 | ORTHO | 6904577 | 6904576 | 2017-03-23 |
| 10758750012817 | ORTHO | 6904577 | 6904577 | 2016-08-24 |
| 10758750003020 | BIOCLONE | 711220 | 711220 | 2014-10-22 |
| 10758750003075 | BIOCLONE | 711320 | 711320 | 2014-10-22 |
| 10758750003129 | BIOCLONE | 711520 | 711520 | 2014-10-22 |
| 10758750003198 | BIOCLONE | 713080 | 713080 | 2014-10-22 |
| 10758750003259 | BIOCLONE | 713180 | 713180 | 2014-10-22 |
| 10758750003266 | BIOCLONE | 714080 | 714080 | 2014-10-22 |
| 10758750003297 | BIOCLONE | 714180 | 714180 | 2014-10-22 |
| 10758750003389 | BIOCLONE | 715280 | 715280 | 2014-10-22 |
| 10758750003662 | BIOCLONE | 717380 | 717380 | 2014-10-22 |
| 10758750003822 | ORTHO | 719000 | 719000 | 2014-10-22 |
| 10758750003839 | SURGISCREEN | 719100 | 719100 | 2014-10-22 |
| 10758750003877 | AFFIRMAGEN | 719201 | 719201 | 2014-10-22 |
| 10758750003907 | AFFIRMAGEN | 719210 | 719210 | 2014-10-22 |
| 10758750003914 | AFFIRMAGEN | 719211 | 719211 | 2014-10-22 |
| 10758750003952 | ORTHO | 719310 | 719310 | 2014-10-22 |
| 10758750003976 | RESOLVE | 719410 | 719410 | 2014-10-22 |
| 10758750003990 | RESOLVE | 719510 | 719510 | 2014-10-22 |