PL.396 Immersion Oil — CE/IVD documentation package for ISO 15189 / CAP / CLIA
PL.396 is one of a small number of microscopy immersion oils sold with full IVD documentation. Below is the documentation package as it lands in your accreditation file — CE/IVD declaration, ISO 13485 manufacturer certificate, DBP-free composition statement, and the SVHC substitution justification accreditation auditors increasingly look for.
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Documents in this package
| Document | Used for |
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| Instructions for Use (IFU) Rev. 2025-01 — carries the IVD symbol | CAP Anatomic/Clinical files; CLIA documentation |
| CE Declaration of Conformity (IVD Directive 98/79/EC) | ISO 15189 vendor file; CE/IVD jurisdictions |
| ISO 13485:2016 manufacturer certificate (NQA ANAB-accredited) | Vendor qualification; quality system audit |
| DBP-free composition statement (REACH Annex XVII alignment) | EHS / occupational exposure file; Prop 65 documentation |
| Per-batch Certificate of Analysis (refractive index, viscosity, fluorescence) | Lot release record; CAP reagent QC file |
Regulatory positioning
- CE Marked as an In Vitro Diagnostic medical device under IVD Directive 98/79/EC. The IVD symbol appears on the IFU.
- ISO 13485:2016 manufacturer (NQA / ANAB accredited).
- DBP-free. Dibutyl phthalate is restricted under EU REACH Annex XVII (effective July 2020), classified as a Reproductive Toxicant Cat. 1B, and listed on California Prop 65.
- Suitable for fluorescence microscopy — produces no residual autofluorescence. The same bottle covers routine 1000× oil immersion and AFB auramine-rhodamine / immunofluorescence work.
- Storage: 15–25°C in original container. Optimal image clarity at 23°C (refractive index optimised at room temperature; per IFU Rev. 2025-01).
Why the DBP question matters in audits
In US labs there is currently no regulatory mandate to substitute DBP-containing immersion oils. In ISO 15189 and EU-aligned environments, SVHC (Substance of Very High Concern) substitution is best practice that auditors increasingly verify. Documenting that a DBP-free oil exists at comparable performance and that you have substituted is the audit-ready answer.
Comparison with common alternatives
| Attribute | PL.396 (50 mL) | Nikon Type N (MXA22203, 50 mL) | Sigma 56822 |
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| Direct list price | $39.99 | $52.80 | ~$22.58 |
| CE/IVD marked | Yes | No | No (research grade) |
| DBP-free declaration | Yes | Not stated | Not stated |
| ISO 13485 manufacturer | Yes (NQA/ANAB) | N/A | N/A |
| Suitable for fluorescence | Yes | Yes | Variable |
Source: pricing per Nikon distributor (spectraservices.com, April 2026); Sigma per current catalog. PL.396 is $12.81 less per bottle than Nikon Type N.
Vendor onboarding shortcut
If your lab already orders other Pro-Lab IVD products (PL.390 oxidase, PLD-series loops, PL.850 coagulase plasma, etc.), adding PL.396 is a line-item add under an existing vendor relationship — no new vendor qualification required.
Use procedure (per IFU Rev. 2025-01)
- Focus on the specimen using a dry objective (×40), keeping the field centred.
- Move the dry objective aside and place a drop of PL.396 on the specimen; rotate the oil immersion lens into place ensuring contact with the oil drop.
- View and make fine focus adjustments.
- After use, clean the oil from the lens using a soft tissue (lens tissue or microfiber).
Reply if you want the IFU PDF, the CE Declaration, or the ISO 13485 manufacturer certificate as separate file attachments for your accreditation binder.
View this document online: https://www.pro-lab-direct.com/general/deliverables/pl396-ivd-package.html
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