Identity
- Trade Name
- PreciControl AMH FDA UDI
- Generic Name
- Anti-Mullerian hormone (AMH) IVD, control FDA UDI
- Model / Reference
- 06709966190 FDA UDI
Identifiers
- Catalog Number
- 06709966190 FDA UDI
- Primary DI / UDI-DI
- 04015630934034 FDA UDI
- 510(k) Number
- DEN150057 FDA UDI
- FDA Product Code
- JJX 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
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
No
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
No
FDA UDI
Category: Anti-Mullerian hormone (AMH) IVD, control
PreciControl AMH by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-Mullerian hormone (AMH) IVD, control.
- Liquichek — Bio-Rad Laboratories · Class I
- AMH CONTROL LEVEL 3 (AMH CONTROL 3) — Randox Laboratories, Ltd. · Class I
- Atellica IM AMH QC Kit — Siemens Healthcare Diagnostics · Class I
- Atellica IM AMH MCM Set — Siemens Healthcare Diagnostics · Class I
- 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
Cleared under the same submission
DEN150057 also covers:
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 8a2396ce-667b-4001-8bf7-abe89c012080 35 fields · synced Jun 1, 2026