Verification evidence is still being completed.
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Wallac Oy (Revvity)
Turku, Finland
- Verified lead
- Petra Furu
- Lead status
- STATUS: VERIFIED APRIL 2026
- Leadership verification
- General Manager, Reproductive Health (Turku)
- 2026 technical specialization
- Neonatal and Prenatal Screening Assays, Time-Resolved Fluorescence, and Clinical Diagnostics Software
- Review cycle
- 24 April 2026
- Full address
- Mustionkatu 6, 20750 Turku, Finland
- Site coordinates
- Verification evidence is still being completed.
- Editorial review
- Memel Biotech editorial review
- Official leadership source
- Business Finland case study naming Petra Furu as General Manager of the Reproductive Health unit in Turku.
- Editorial note
- Turku IVD manufacturing and R&D site for global neonatal and prenatal screening with ISO 13485 and FDA-registered credentials, now part of Revvity.
Neonatal and Prenatal Screening Assays, Time-Resolved Fluorescence, and Clinical Diagnostics Software
ISO 13485 certified, FDA 510(k) history, CE-IVD / IVDR coverage
Turku IVD manufacturing and R&D site for global neonatal and prenatal screening with ISO 13485 and FDA-registered credentials, now part of Revvity.
Review coverage
Leadership
Facility
Certifications
Capabilities
Partners
Sources
Quality
Editorial verificationMemel Biotech directory review sign-off
Report generated02 Jun 2026, 01:40
Company profile · Turku, Finland
Wallac Oy (Revvity)
Neonatal and Prenatal Screening Assays, Time-Resolved Fluorescence, and Clinical Diagnostics Software · Commercial IVD manufacturing
Turku IVD manufacturing and R&D site for global neonatal and prenatal screening with ISO 13485 and FDA-registered credentials, now part of Revvity.
- Lead
- Petra Furu (verified ↗)
- Address
- Mustionkatu 6, 20750 Turku, Finland (source ↗)
- Compliance
- ISO 13485 certified · FDA 510(k) history · CE-IVD / IVDR coverage
- Last reviewed
- 24 Apr 2026 (1mo ago)
- Scale
- Commercial IVD manufacturing
- Capabilities
- IVD Assay Development and Manufacturing · Global Newborn Screening Kit Supply · Clinical Diagnostics Software
- Founded
- 1950
- Headcount
- 501-1000
- Company page (open ↗)
Clinical profileSTATUS: VERIFIED APRIL 2026
Petra Furu
General Manager, Reproductive Health (Turku)
Full addressMustionkatu 6, 20750 Turku, Finland
Site coordinatesVerification evidence is still being completed.
Review cycle24 April 2026
Physical site source
FDA/ICIJ manufacturer registry entry listing Wallac Oy at Mustionkatu 6, Turku.
Open sourceCommercial IVD manufacturing
Turku, Finland. Neonatal and Prenatal Screening Assays, Time-Resolved Fluorescence, and Clinical Diagnostics Software. Review completed on 24 Apr 2026.
Fimea and FDA for IVD oversight
ISO 13485 certified, FDA 510(k) history, CE-IVD / IVDR coverage
Neonatal and Prenatal Screening Assays, Time-Resolved Fluorescence, and Clinical Diagnostics Software
Turku IVD manufacturing and R&D site for global neonatal and prenatal screening with ISO 13485 and FDA-registered credentials, now part of Revvity.
Editorial note
Wallac Oy is the Turku-based Revvity (formerly PerkinElmer) reproductive-health and neonatal-screening site with documented ISO 13485 and FDA 510(k) credentials; the named site lead is per the 2022 Business Finland record.
FULL TRUST REVIEW COMPLETE
Shown only when all seven trust checks are fully mapped in the directory.
Current review cycleApril 2026
Capabilities
Core capabilities
Primary declared technical activities and areas of operating focus.
IVD Assay Development and Manufacturing
Global Newborn Screening Kit Supply
Clinical Diagnostics Software
Verification source dossier
Verification source dossier
Official source set used to support leadership, physical-site, certification, and watch-note evidence.
Infrastructure
Declared infrastructure
DELFIA and AutoDELFIA assay manufacturing
Screening instrument production
Clinical diagnostics software
Regulatory posture
Quality system coverage
GMP / GLP / ISO-13485 / FDA-Inspected are global quality-system standards. "Verified active" means the directory confirmed the certification is current; "Review in progress" means the cert status is currently being re-verified.
- GMP
- VERIFIED ACTIVE 2026
- GLP
- REVIEW IN PROGRESS 2026
- ISO-13485
- VERIFIED ACTIVE 2026
- FDA-Inspected
- VERIFIED ACTIVE 2026
Verification history
Verification history
24 Apr 2026: Executive identity confirmed via official management disclosure.
24 Apr 2026: Full trust review completed.
FAQ
Frequently asked questions
- Where is Wallac Oy (Revvity) located?
- Wallac Oy (Revvity) operates from Mustionkatu 6, 20750 Turku, Finland, Turku, Finland.
- Who runs Wallac Oy (Revvity)?
- Wallac Oy (Revvity) is led by Petra Furu, General Manager, Reproductive Health (Turku). Verified 24 Apr 2026.
- What certifications does Wallac Oy (Revvity) hold?
- Wallac Oy (Revvity) is documented under ISO 13485 certified, FDA 510(k) history, CE-IVD / IVDR coverage.
- What does Wallac Oy (Revvity) do?
- Turku IVD manufacturing and R&D site for global neonatal and prenatal screening with ISO 13485 and FDA-registered credentials, now part of Revvity. Core capabilities: IVD Assay Development and Manufacturing, Global Newborn Screening Kit Supply, Clinical Diagnostics Software.
Editorial context
Related technical briefs
Briefs that name Turku as a covered market or city.