Identity
- Trade Name
- Ansh Labs AnshCheck AMH Tri-Level Controls FDA UDI
- Generic Name
- Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Ansh Labs AMH Tri-Level Controls are intended for use as assay quality controls to monitor the precision and reproducibility of laboratory testing methods for the determination of AMH in serum, plasma or other biological fluids. Tri-level controls are run as unknowns against kit calibrators in any human AMH assays. FDA UDI
- Model / Reference
- AL-CTR-401-i FDA UDI
- Description
- Ansh Labs AMH Tri-Level Controls are intended for use as assay quality controls to monitor the precision and reproducibility of laboratory testing methods for the determination of AMH in serum, plasma or other biological fluids. Tri-level controls are run as unknowns against kit calibrators in any human AMH assays. FDA UDI
Identifiers
- Catalog Number
- AL-CTR-401-i FDA UDI
- Primary DI / UDI-DI
- 00853592008103 FDA UDI
- GMDN Term
- Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)
Ansh Labs AnshCheck AMH Tri-Level Controls by Ansh Labs, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Elecsys AMH — Roche Diagnostics Corp. · Class II
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Ansh Labs, LLC
Sources (1)
- FDA UDI 33c433ef-7f01-4940-82e4-0d6112a6f0c0 35 fields · synced May 30, 2026