Identity
- Trade Name
- AMH Control FDA UDI
- Generic Name
- Anti-Mullerian hormone (AMH) IVD, control FDA UDI
- Model / Reference
- 660-20 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17350066140579 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Anti-Mullerian hormone (AMH) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
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, control
AMH Control by Fujirebio Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-Mullerian hormone (AMH) IVD, control.
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- AMH CONTROL LEVEL 4 (AMH CONTROL 4) — Randox Laboratories, Ltd. · Class I
- AMH CONTROL LEVEL 1 (AMH CONTROL 1) — Randox Laboratories, Ltd. · Class I
- AMH CONTROL LEVEL 2 (AMH CONTROL 2) — Randox Laboratories, Ltd. · Class I
- ADVIA Centaur AMH QC Kit — Siemens Healthcare Diagnostics · Class I
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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fujirebio Diagnostics, Inc.
Sources (1)
- FDA UDI 3d55136a-f9f3-4313-b237-d6a99c669abe 35 fields · synced Jun 9, 2026