Monobind AccuLite CA 125 CLIA Kit - 192 Wells
- Primary DI
- 00816870022161
- Brand
- Monobind AccuLite CA 125 CLIA Kit - 192 Wells
- Company
- MONOBIND, INC.
- Model
- 3075-300
- Catalog number
- 3075-300B
- Published
- 2019-02-11
- 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
monobind.comProduct Codes
| Code | Name |
|---|---|
| LTK | TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | Immunology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00816870022161 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00816870022161 | 00816870022161 | 816870022161 | 0816870022161 |
GMDN Terms
| Term | Definition |
|---|---|
| Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 125 (CA125), a marker commonly associated with ovarian cancer, in a clinical specimen using a chemiluminescent immunoassay method. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Width | 7.75 | Inch |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(949)951-2665 | info@monobind.com |
Regulatory Flags
- DUNS number
- 083155515
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07613336218327 | Elecsys CA 125 II | Roche Diagnostics GmbH | LTK | 2024-08-13 |
| 10758750034826 | VITROS | ORTHO CLINICAL DIAGNOSTICS | LTK | 2023-03-14 |
| 10758750034901 | VITROS | ORTHO CLINICAL DIAGNOSTICS | LTK | 2023-03-14 |
| 00630414294278 | Atellica IM CA 125II | Siemens Healthcare Diagnostics Inc. | LTK | 2020-05-31 |
| 00380740131043 | Alinity | Abbott GmbH & Co. KG | LTK | 2019-02-12 |
| 00816870020471 | Monobind AccuBind CA 125 ELISA Kit - 96 Wells | MONOBIND, INC. | LTK | 2019-02-11 |
| 00816870020488 | Monobind AccuBind CA 125 ELISA Kit - 192 Wells | MONOBIND, INC. | LTK | 2019-02-11 |
| 00816870022154 | Monobind AccuLite CA 125 CLIA Kit - 96 Wells | MONOBIND, INC. | LTK | 2019-02-11 |
| 00380740145361 | ARCHITECT | Abbott GmbH & Co. KG | LTK | 2019-01-21 |
| 00380740145378 | ARCHITECT | Abbott GmbH & Co. KG | LTK | 2019-01-21 |
| 00380740145385 | ARCHITECT | Abbott GmbH & Co. KG | LTK | 2019-01-21 |
| 00380740131050 | Alinity | Abbott GmbH & Co. KG | LTK | 2018-12-31 |
| 00630414598116 | Atellica IM CA 125II MCM | Siemens Healthcare Diagnostics Inc. | LTK | 2017-12-27 |
| 00630414598086 | Atellica IM CA 125II | Siemens Healthcare Diagnostics Inc. | LTK | 2017-12-22 |
| 00630414598093 | Atellica IM CA 125II | Siemens Healthcare Diagnostics Inc. | LTK | 2017-12-22 |
| 00630414598109 | Atellica IM CA 125II Calibrator | Siemens Healthcare Diagnostics Inc. | LTK | 2017-12-22 |
| 14560189210216 | ST AIA-PACK CA 125 | TOSOH CORPORATION | LTK | 2016-09-24 |
| 04560189211131 | AIA-PACK CA 125 Sample Diluting Solution | TOSOH CORPORATION | LTK | 2016-09-24 |
| 04560189211148 | AIA-PACK CA 125 Calibrator Set | TOSOH CORPORATION | LTK | 2016-09-24 |
| 00842768028519 | Dimension Vista® Flex® reagent cartridge CA125 | Siemens Healthcare Diagnostics Inc. | LTK | 2016-09-24 |
| 00630414461274 | ADVIA Centaur® CA 125II MCM | Siemens Healthcare Diagnostics Inc. | LTK | 2016-09-24 |
| 00630414461298 | ADVIA Centaur® CA 125II | Siemens Healthcare Diagnostics Inc. | LTK | 2016-09-24 |
| 00630414461304 | ADVIA Centaur® CA 125 II | Siemens Healthcare Diagnostics Inc. | LTK | 2016-09-24 |
| 00630414461335 | ADVIA Centaur® Systems CA 125II Calibrator | Siemens Healthcare Diagnostics Inc. | LTK | 2016-09-24 |
| 00630414954127 | IMMULITE®/IMMULITE® 1000 Systems OMM OM-MA Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | LTK | 2016-09-24 |
| 00630414954134 | IMMULITE® 2000 Systems OM-MA Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | LTK | 2016-09-24 |
| 00630414954219 | IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | LTK | 2016-09-24 |
| 00630414961798 | IMMULITE® 2000 Systems OV OM-MA (CA125) | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | LTK | 2016-09-24 |
| 00630414964331 | IMMULITE®/IMMULITE® 1000 Systems OV OM-MA (CA 125) | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | LTK | 2016-09-24 |
| 04987270234273 | Lumipulse G CA125II Immunoreaction Cartridges | FUJIREBIO INC. | LTK | 2016-09-16 |