FDA UDI
In Commercial Distribution
🇺🇸 United States
Access Progesterone II
DI: 15099590752682
·
Model: C78020
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Access Progesterone II
- Primary DI
- 15099590752682
- Version / Model
- C78020
- Catalog Number
- C78020
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-01
- Public Version
- 1
- Public Version Date
- 2024-03-11
- Public Version Status
- New
- Public Device Record Key
- 3abb5eef-7ca4-48c1-bd09-bc6e92ecf921
Device Description
The Access Progesterone II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of progesterone levels in human serum and plasma (lithium heparin) using the automated Access 2 Immunoassay System and DxI 9000 Access Immunoassay Analyzer. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
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
- Yes
- 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 |
|---|---|---|---|---|
| JLS | Radioimmunoassay, Progesterone | Clinical Chemistry | 862.1620 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54322 | Progesterone IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of progesterone in a clinical specimen, using a chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590752682 | GS1 |