Monobind AccuLite CA 19-9 CLIA Kit - 96 Wells
- Primary DI
- 00816870022192
- Brand
- Monobind AccuLite CA 19-9 CLIA Kit - 96 Wells
- Company
- MONOBIND, INC.
- Model
- 3975-300
- Catalog number
- 3975-300A
- 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
Product Codes
| Code | Name |
|---|
| NIG | SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | Immunology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00816870022192 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00816870022192 | 00816870022192 | 816870022192 | 0816870022192 |
GMDN Terms
| Term | Definition |
|---|
| Cancer antigen 19-9 (CA19-9) 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 19-9 (CA19-9) in a clinical specimen, using a chemiluminescent immunoassay method. CA19-9 is typically used as a marker commonly associated with gastrointestinal, pancreatic, bile duct and gallbladder cancer. |
Device Sizes
| Type | Value | Unit |
|---|
| Width | 7.75 | Inch |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Handling Environment Temperature |
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
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
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00816870020006 | NeoLumax CLIA Analyzer | IN010 | IN010 | 2024-09-13 |
| 00816870020013 | LuMatic CLIA Analyzer | IN008 | IN008 | 2024-09-13 |
| 00816870020044 | Immunoassay Plate Washer | IN002 | IN002 | 2024-09-13 |
| 00816870020051 | NeoEldex ELISA Analyzer | IN009 | IN009 | 2024-09-13 |
| 00816870020068 | PrisMatic ELISA Analyzer | IN013 | IN013 | 2024-09-13 |
| 00816870020075 | Autoplex G1 ELISA Analyzer | IN006 | IN006 | 2024-09-13 |
| 00816870020082 | Autoplex G2 ELISA + CLIA Analyzer | IN006-2 | IN006-2 | 2024-09-13 |
| 00816870020402 | PTH Intact AccuBind ELISA Test System - 96 Wells | 9025-300 | 9025-300A | 2024-09-13 |
| 00816870021010 | PAPP-A AccuBind ELISA Test System - 192 Wells | 12625-300 | 12625-300B | 2024-09-13 |
| 00816870021164 | N-17-OHP AccuBind ELISA Test System - 96 Wells | 5525-300 | 5525-300A | 2024-09-13 |
| 00816870021171 | N-17-OHP AccuBind ELISA Test System - 192 Wells | 5525-300 | 5525-300B | 2024-09-13 |
| 00816870021188 | N-17-OHP AccuBind ELISA Test System - 480 Wells | 5525-300 | 5525-300D | 2024-09-13 |
| 00816870021195 | N-17-OHP AccuBind ELISA Test System - 960 Wells | 5525-300 | 5525-300E | 2024-09-13 |
| 00816870021201 | N-17-OHP AccuBind ELISA Test System - 1920 Wells | 5525-300 | 5525-300F | 2024-09-13 |
| 00816870021294 | 903 DBS Collection Cards - 6 Samples | 329MM | 329MM | 2024-09-13 |
| 00816870021300 | 903 DBS Collection Cards - 5 Samples | 621MM | 621MM | 2024-09-13 |
| 00816870022642 | PAPP-A AccuLite CLIA Test System - 96 Wells | 12675-300 | 12675-300A | 2024-09-13 |
| 00816870022659 | PAPP-A AccuLite CLIA Test System - 192 Wells | 12675-300 | 12675-300B | 2024-09-13 |
| 00816870023366 | Vit D Direct AccuLite CLIA Test System - 96 wells | 9475-300 | 9475-300A | 2024-09-13 |
| 00816870023373 | Vit D Direct AccuLite CLIA Test System - 192 wells | 9475-300 | 9475-300B | 2024-09-13 |
Other Devices Sharing Product Codes
monobind.com