Audit MicroControls MethodVal FD Procalcitonin bioMerieux VIDAS and miniVIDAS

FDA UDI

by Aalto Scientific, Ltd.

Identity

Trade Name: Audit MicroControls MethodVal FD Procalcitonin bioMerieux VIDAS and miniVIDAS FDA UDI
Generic Name: Procalcitonin (PCT) IVD, control FDA UDI
Model / Reference: K842M-25 FDA UDI

Identifiers

Primary DI / UDI-DI: B085K842M250 FDA UDI
GMDN Term: Procalcitonin (PCT) IVD, control FDA UDI

Classification

Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Procalcitonin (PCT) IVD, control

Audit MicroControls MethodVal FD Procalcitonin bioMerieux VIDAS and miniVIDAS by Aalto Scientific, Ltd. — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Procalcitonin (PCT) IVD, control.

LIAISON Controls BRAHMS PCT II GEN — Diasorin Inc.
VITROS — Ortho-Clinical Diagnostics · Class II
Atellica IM BRAHMS PCT QC Kit — Siemens Healthcare Diagnostics · Class I
Elecsys PCT CalCheck 5 — Roche Diagnostics Corp. · Class I
Alinity — Abbott Ireland Diagnostics · Class I
Atellica IM PCT QC — Siemens Healthcare Diagnostics · Class II
VITROS — Ortho-Clinical Diagnostics · Class II
LIAISON BRAHMS PCT II GEN Verifiers — Diasorin Inc.

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 5c28ad39-e50a-4526-a5f7-6ee6b0485711 32 fields · synced May 29, 2026