FDA UDI
In Commercial Distribution
🇺🇸 United States
Access AMH
DI: 15099590669263
·
Model: B13127
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Access AMH
- Primary DI
- 15099590669263
- Version / Model
- B13127
- Catalog Number
- B13127
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-16
- Public Version
- 2
- Public Version Date
- 2023-07-26
- Public Version Status
- Update
- Public Device Record Key
- 0fe7738b-ebe4-4776-beb9-342567602a5b
Device Description
The Access AMH assay is paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and lithium heparin plasma using the Access Immunoassay Systems as an aid in the assessment of ovarian reserve in women presenting to fertility clinics.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| PQO | Anti-Müllerian Hormone Test System | Clinical Chemistry | 862.1092 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58413 | Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the quantitative measurement of anti-Mullerian hormone (AMH) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590669263 | GS1 |