Identity
- Trade Name
- Liquichek FDA UDI
- Generic Name
- Anti-Mullerian hormone (AMH) IVD, control FDA UDI
- Device Name
- Liquichek AMH Control Trilevel (A human serum assayed AMH control.) FDA UDI
- Model / Reference
- 12006327 FDA UDI
- Description
- Liquichek AMH Control Trilevel (A human serum assayed AMH control.) FDA UDI
Identifiers
- Catalog Number
- 12006327 FDA UDI
- Primary DI / UDI-DI
- 03610521176510 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
No
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
Yes
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
Liquichek by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-Mullerian hormone (AMH) IVD, control.
- 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
- ADVIA Centaur MH MCM Set — 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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 036fabc7-2a92-44f6-991f-e3bd5b433226 36 fields · synced May 30, 2026