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Audit MicroControls Linearity FLQ Anti-Mullerian Hormone for Roche Systems
FDA UDIIdentity
- Trade Name
- Audit MicroControls Linearity FLQ Anti-Mullerian Hormone for Roche Systems FDA UDI
- Generic Name
- Anti-Mullerian hormone (AMH) IVD, control FDA UDI
- Model / Reference
- K896M-5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B085K896M50 FDA UDI
- GMDN Term
- Anti-Mullerian hormone (AMH) IVD, control FDA UDI
Classification
- 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
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
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
Audit MicroControls Linearity FLQ Anti-Mullerian Hormone for Roche Systems by Aalto Scientific, Ltd. — FDA UDI — listed in FDA GUDID
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
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
- Aalto Scientific, Ltd.
Sources (1)
- FDA UDI c5eeb2af-af35-4b67-b8e3-27dddc491234 32 fields · synced May 30, 2026