FDA UDI
In Commercial Distribution
🇺🇸 United States
Access GI Monitor
DI: 15099590231842
·
Model: 387687
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Access GI Monitor
- Primary DI
- 15099590231842
- Version / Model
- 387687
- Catalog Number
- 387687
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 5
- Public Version Date
- 2023-07-26
- Public Version Status
- Update
- Public Device Record Key
- f48f4909-9efd-454c-aa3a-7d307924cf7f
Device Description
The Access GI Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 19-9 antigen levels in human serum and plasma using the Access Immunoassay Systems.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | Immunology | 866.6010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54573 | Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA) | 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 an enzyme immunoassay (EIA) method. CA19-9 is typically used as a marker commonly associated with gastrointestinal, pancreatic, bile duct and gallbladder cancer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590231842 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033038 | 000 |