Alinity
- Primary DI
- 00380740117191
- Brand
- Alinity
- Company
- Abbott GmbH & Co. KG
- Model
- 06P0460
- Catalog number
- 06P0460
- Device description
- Alinity s Anti-HCV Reagent Kit
- Published
- 2019-09-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Contact Domains
xx.xxIdentifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00380740117191 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00380740117191 | 00380740117191 | 380740117191 | 0380740117191 |
GMDN Terms
| Term | Definition |
|---|---|
| Hepatitis C virus total antibody IVD, kit, chemiluminescent assay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis C virus in a clinical specimen, using a chemiluminescent immunoassay method. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| 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
- 315786293
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00380740138332 | Alinity | 07P6031 | 07P6031 | 2020-05-29 |
| 00380740192457 | Alinity | 06R901A | 06R901A | 2020-05-18 |
| 00380740170264 | Alinity | 09P521A | 09P521A | 2020-05-11 |
| 00380740170271 | Alinity | 09P523A | 09P523A | 2020-05-11 |
| 00380740121754 | Alinity | 08P0721 | 08P0721 | 2020-05-06 |
| 00380740121778 | Alinity | 08P0731 | 08P0731 | 2020-05-06 |
| 00380740136574 | Alinity | 08P0712 | 08P0712 | 2020-05-06 |
| 00380740146252 | Alinity | 08P0702 | 08P0702 | 2020-05-06 |
| 00380740151744 | Alinity | 09P411A | 09P411A | 2020-05-01 |
| 00380740154387 | Alinity | 08P073A | 08P073A | 2020-05-01 |
| 00380740163556 | ARCHITECT | 5P56-02 | 05P5602 | 2020-05-02 |
| 00380740161798 | ARCHITECT | 7D79-22 | 07D7922 | 2020-04-18 |
| 00380740161804 | ARCHITECT | 7D79-32 | 07D7932 | 2020-04-18 |
| 00380740190361 | ARCHITECT | 08K2804 | 08K2804 | 2020-04-15 |
| 00380740190378 | ARCHITECT | 08K2813 | 08K2813 | 2020-04-15 |
| 00380740154325 | Alinity | 09P1403 | 09P1403 | 2018-07-30 |
| 00380740174965 | ARCHITECT | 6L45-22 | 06L4522 | 2020-04-12 |
| 00380740174972 | ARCHITECT | 6L45-42 | 06L4542 | 2020-04-12 |
| 00380740170318 | Alinity | 09P551A | 09P551A | 2020-03-27 |
| 00380740170325 | Alinity | 09P553A | 09P553A | 2020-03-27 |