Monobind AccuLite CEA Next Generation CLIA Kit - 96 Wells
- Primary DI
- 00816870022239
- Brand
- Monobind AccuLite CEA Next Generation CLIA Kit - 96 Wells
- Company
- MONOBIND, INC.
- Model
- 4675-300
- Catalog number
- 4675-300A
- 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
Related Records
Contact Domains
monobind.comProduct Codes
| Code | Name |
|---|---|
| DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DHX | System, Test, Carcinoembryonic Antigen | Immunology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00816870022239 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00816870022239 | 00816870022239 | 816870022239 | 0816870022239 |
GMDN Terms
| Term | Definition |
|---|---|
| Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of carcinoembryonic antigen (CEA) 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 |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Handling Environment Temperature |
| 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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