FDA UDI
In Commercial Distribution
🇺🇸 United States
AMH CONTROL LEVEL 2 (AMH CONTROL 2)
DI: 05055273217780
·
Model: AMH10514
·
RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AMH CONTROL LEVEL 2 (AMH CONTROL 2)
- Primary DI
- 05055273217780
- Version / Model
- AMH10514
- Catalog Number
- AMH10514
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-02
- Public Version
- 1
- Public Version Date
- 2022-09-12
- Public Version Status
- New
- Public Device Record Key
- 1460b7a2-22b9-4566-9b59-04615f291ded
Device Description
The AMH Control Level 2 (AMH10514) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 2 (AMH10514) is assayed with target values and is suitable for use on automated analysers. The AMH Control Level 2 (AMH10514) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58411 | Anti-Mullerian hormone (AMH) IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of anti-Mullerian hormone (AMH) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273217780 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -70 – -20 Degrees Celsius