Identity
- Trade Name
- Ansh Labs Dried Blood Spot (DBS) AMH ELISA FDA UDI
- Generic Name
- Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Anti-Müllerian hormone (DBS AMH) enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of AMH in human dried blood spot. This kit is intended for in-vitro diagnostic use only. FDA UDI
- Model / Reference
- AL-129-i FDA UDI
- Description
- The Anti-Müllerian hormone (DBS AMH) enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of AMH in human dried blood spot. This kit is intended for in-vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- AL-129-i FDA UDI
- Primary DI / UDI-DI
- 00853592008134 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
No
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 Dried Blood Spot (DBS) AMH ELISA by Ansh Labs, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA).
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- Elecsys AMH — Roche Diagnostics Corp. · Class II
- 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 103d218a-d7c5-46c3-a033-da7a0a8d0637 35 fields · synced May 30, 2026