Monobind AccuLite CA 15-3 CLIA Kit - 96 Wells
- Primary DI
- 00816870022178
- Brand
- Monobind AccuLite CA 15-3 CLIA Kit - 96 Wells
- Company
- MONOBIND, INC.
- Model
- 5675-300
- Catalog number
- 5675-560A
- 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 |
|---|
| MOI | SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MOI | System, Test, Immunological, Antigen, Tumor | Immunology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00816870022178 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00816870022178 | 00816870022178 | 816870022178 | 0816870022178 |
GMDN Terms
| Term | Definition |
|---|
| Cancer antigen 15-3 (CA15-3) 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 15-3 (CA15-3), a marker commonly associated with breast 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 | |
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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|---|
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| 00816870020075 | Autoplex G1 ELISA Analyzer | IN006 | IN006 | 2024-09-13 |
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| 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 |
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| 00816870021195 | N-17-OHP AccuBind ELISA Test System - 960 Wells | 5525-300 | 5525-300E | 2024-09-13 |
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| 00816870021294 | 903 DBS Collection Cards - 6 Samples | 329MM | 329MM | 2024-09-13 |
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| 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