Alinity
- Primary DI
- 00380740150686
- Brand
- Alinity
- Company
- Abbott GmbH & Co. KG
- Model
- 09P5920
- Catalog number
- 09P5920
- Device description
- Alinity c Haptoglobin Reagent Kit 180 Tests
- Published
- 2019-07-08
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Contact Domains
xx.xxProduct Codes
| Code | Name |
|---|---|
| DAD | HAPTOGLOBIN, ANTIGEN, ANTISERUM, CONTROL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DAD | Haptoglobin, Antigen, Antiserum, Control | Immunology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00380740150686 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00380740150686 | 00380740150686 | 380740150686 | 0380740150686 |
GMDN Terms
| Term | Definition |
|---|---|
| Haptoglobin 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 quantitative measurement of haptoglobin in a clinical specimen. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Temperature | 0 | 30 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
- 315786293
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- 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 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00630414305080 | Atellica CH HAPT2 | Siemens Healthcare Diagnostics Inc. | DAD | 2023-08-28 |
| 00380740169879 | Alinity | ABBOTT IRELAND | DAD | 2021-05-13 |
| 00380740169886 | ARCHITECT | ABBOTT IRELAND | DAD | 2021-03-19 |
| 07613336140772 | Tina-quant Haptoglobin ver.2 | Roche Diagnostics GmbH | DAD | 2020-03-05 |
| 05055273203806 | HAPTOGLOBIN (HP) | RANDOX LABORATORIES LIMITED | DAD | 2019-06-03 |
| 06970291985161 | Haptoglobin Kit (Immunoturbidimetric Method) | Medicalsystem Biotechnology Co., Ltd. | DAD | 2019-03-07 |
| 00630414210827 | Atellica™ CH Hapt | Siemens Healthcare Diagnostics Inc. | DAD | 2018-12-08 |
| 15099590010621 | AU | Beckman Coulter, Inc. | DAD | 2016-09-24 |
| B1761120 | Antiserum to Human Haptoglobin | KENT LABORATORIES INC | DAD | 2016-09-24 |
| 05051700016094 | Human Haptoglobin Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | DAD | 2016-09-24 |
| 05051700017626 | Optilite Haptoglobin Kit | THE BINDING SITE GROUP LIMITED | DAD | 2016-09-24 |
| 00842768006111 | DImension Vista® Haptoglobin Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | DAD | 2016-09-24 |
| 00630414491356 | ADVIA® Chemistry HAPT Haptoglobin Reagents | Siemens Healthcare Diagnostics Inc. | DAD | 2016-09-24 |
| 00630414506005 | ADVIA® Chemistry HAPT Haptoglobin Reagents | Siemens Healthcare Diagnostics Inc. | DAD | 2016-09-24 |
| 00816426020153 | K-ASSAY® Haptoglobin Reagent | KAMIYA BIOMEDICAL COMPANY, LLC | DAD | 2016-09-16 |
| 10758750002283 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | DAD | 2016-08-26 |
| 15099590224431 | Synchron | Beckman Coulter, Inc. | DAD | 2016-08-24 |
| 15099590230456 | IMMAGE | Beckman Coulter, Inc. | DAD | 2016-08-24 |
| 00380740019693 | ARCHITECT | ABBOTT LABORATORIES | DAD | 2016-06-06 |