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Audit MicroControls Linearity FLQ Fertility for Abbott Systems
FDA UDIIdentity
- Trade Name
- Audit MicroControls Linearity FLQ Fertility for Abbott Systems FDA UDI
- Generic Name
- Multiple human hormone IVD, control FDA UDI
- Model / Reference
- K947M-5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B085K947M50 FDA UDI
- GMDN Term
- Multiple human hormone 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: Multiple human hormone IVD, control
Audit MicroControls Linearity FLQ Fertility for Abbott Systems by Aalto Scientific, Ltd. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Lyphochek — Bio-Rad Laboratories · Class I
- Lyphochek — Bio-Rad Laboratories · 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 b21ffb64-236b-4a78-845f-e4f5f384ac72 32 fields · synced May 31, 2026