Is Pro-Lab PL.396 immersion oil DBP-free?

Yes. PL.396 is formulated without Dibutyl Phthalate (DBP), a reproductive toxicant restricted under EU REACH Annex XVII (July 2020) and listed on California Prop 65. DBP is classified as a Reproductive Toxicant Category 1B. PL.396 eliminates this occupational exposure.

Is PL.396 CE-marked for IVD use?

Yes. Pro-Lab PL.396 carries CE marking as an In Vitro Diagnostic medical device (IVD symbol confirmed on IFU Rev. 2025 01). CE/IVD documentation is available for laboratory accreditation files including ISO 15189, CAP, and CLIA.

DBP-Free Immersion Oil 50ml — IVD CE-Marked

Why Clinical Labs Choose PL.396

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DBP-Free

No Reproductive Toxicant in Your Lab. PL.396 is formulated without Dibutyl Phthalate (DBP), a reproductive toxicant restricted under EU REACH Annex XVII and listed on California Prop 65 — protecting staff from chronic occupational exposure.

Source: IFU Rev. 2025 01

✅

CE/IVD Certified

Documentation Ready for Your Accreditation File. CE marking for In Vitro Diagnostic use provides a documentable compliance record for ISO 15189, CAP, and CLIA laboratory accreditation — not available on research-grade or OEM oils.

Source: IFU Rev. 2025 01

🔬

Fluorescence-Compatible

One Oil for Routine and Fluorescence Protocols. No residual fluorescence — suitable for both conventional brightfield microscopy and fluorescence applications including AFB auramine-rhodamine staining.

Source: pro-lab.com product page

📈

Direct Savings

$12.81 Less Per Bottle Than Nikon Type N. At $39.99/50ml, PL.396 costs $12.81 less per bottle than Nikon Type N (MXA22203 at $52.80/50ml) — with more documented clinical attributes.

Source: spectraservices.com April 2026

Tailored for Your Role

One Oil for Routine and Fluorescence Work — DBP-Free, $39.99/50ml

Most clinical microbiology labs stock two immersion oils: a standard type for routine Gram stain and culture plate work, and a low-fluorescence type for AFB or immunofluorescence. Pro-Lab PL.396 covers both. It produces no residual fluorescence, is CE/IVD-marked for documentation compliance, and is formulated without DBP — the phthalate reproductive toxicant restricted under EU REACH Annex XVII.

✓ DBP-free — eliminates Reproductive Toxicant Cat. 1B from lab environment (IFU Rev. 2025 01)
✓ CE/IVD marked — documentable for accreditation files (IFU Rev. 2025 01)
✓ $12.81 less per bottle than Nikon Type N (spectraservices.com April 2026)

Common questions:

We already use Sigma immersion oil — it's cheaper. Why switch?

Sigma 56822 is a research-grade product with no IVD-CE mark and no DBP-free claim. For a clinical microbiology lab, PL.396 provides IVD documentation for your accreditation file and eliminates a REACH-restricted chemical from your bench — at a $17.41/bottle premium over Sigma.

We have all-Nikon scopes — shouldn't we use Nikon oil?

PL.396 and Nikon Type N both target the same refractive index for standard clinical microscopy work. PL.396 is $12.81 less per bottle, DBP-free, and CE/IVD marked. For all-Nikon labs running fluorescence assays, PL.396 covers both routine and fluorescence in one bottle.

IVD-Certified, DBP-Free — Documentation Ready for CAP and ISO 15189 Files

Accreditation auditors increasingly scrutinize reagent and consumable documentation — not just test performance. IVD-CE marking on consumables like immersion oil provides a documentable compliance record that research-grade alternatives cannot. PL.396 is CE/IVD-marked, DBP-free per REACH Annex XVII, and produced by an ISO 13485-certified manufacturer.

✓ CE/IVD marked — accreditation documentation available (IFU Rev. 2025 01)
✓ DBP-free — eliminates REACH SVHC from lab environment (IFU Rev. 2025 01; ECHA REACH Annex XVII)
✓ ISO 13485 certified manufacturer — NQA/ANAB (pro-lab-direct.com)

Is DBP in immersion oil actually a compliance issue?

In the US, there is currently no mandate. In EU-aligned and ISO 15189 environments, SVHC substitution is a best practice increasingly verified in audits. DBP is EU REACH Annex XVII restricted (July 2020), a Reproductive Toxicant Cat. 1B, and a California Prop 65 listed substance. PL.396 eliminates this exposure with no performance tradeoff.

Is one more vendor worth it just for immersion oil?

Pro-Lab Diagnostics USA is already in your vendor file for other IVD products on pro-lab-direct.com. Adding PL.396 is a line-item add under an existing relationship, not a new vendor qualification.

One Oil for Your Whole Scope — No Background Signal on Fluorescence

If you run AFB auramine-rhodamine or any immunofluorescence assay, standard immersion oils can introduce autofluorescence background that shows up as noise in your field. Pro-Lab PL.396 produces no residual fluorescence — the same bottle you use for routine Gram stain 1000x work is suitable for your fluorescence protocols.

✓ DBP-free — eliminates reproductive toxicant from repeated daily skin-contact exposure (IFU Rev. 2025 01)
✓ Compatible with all major microscope brands (RI matched to glass — IFU Rev. 2025 01)
✓ 4-step procedure: apply, move objective into contact, fine-focus, clean after use (IFU Rev. 2025 01)

How do I clean the oil from the objective lens?

After use, clean the oil from the lens using a soft tissue. (IFU Rev. 2025 01, Procedure Step 4)

Does the oil need to be at a specific temperature for best results?

PL.396 performs optimally at 23°C. It may be stored between 15°C and 25°C and will remain stable, but image clarity is best when the oil is at 23°C room temperature. (IFU Rev. 2025 01)

Technical Specifications — PL.396

Parameter	Value	Source
Catalog number	PL.396	IFU Rev. 2025 01
Volume	50 ml (dropper bottle)	IFU Rev. 2025 01
Intended use	For use in microscopic examination of prepared slides from clinical specimens	IFU Rev. 2025 01
DBP-free	Yes — Free from Dibutyl Phthalate (DBP); non-teratogenic	IFU Rev. 2025 01
Refractive index	Same as glass microscopy slides; optimum at 23°C	IFU Rev. 2025 01
Storage temperature	15–25°C in original container	IFU Rev. 2025 01
Optimum use temperature	23°C	IFU Rev. 2025 01
Shelf life	Until expiry date on label	IFU Rev. 2025 01
CE/IVD marking	CE marked — In Vitro Diagnostic medical device	IFU Rev. 2025 01
EC REP	Advena Ltd., Tower Business Centre, Tower Street, Swatar, BKR 4013, Malta	IFU Rev. 2025 01
Hazard statement	H413 — May cause long lasting harmful effects to aquatic life	IFU Rev. 2025 01
Precautionary statements	P273 — Avoid release to the environment; P501 — Dispose of contents/container per local regulations	IFU Rev. 2025 01
ISO certification	ISO 13485 Certified Manufacturer — NQA/ANAB	pro-lab-direct.com
Price	$39.99 / 50ml	pro-lab-direct.com

Full IFU: IFU Rev. 2025 01 (PDF)

	Pro-Lab PL.396	Sigma 56822	Nikon Type N
Price / 50ml	$39.99	~$22.58	$52.80
DBP-free	✓ Confirmed (IFU)	✗ Not claimed	✗ Not claimed
CE/IVD marked	✓ Yes	✗ No	✗ No
Fluorescence-suitable	✓ Stated	✗ Not stated	✗ Not stated

Procedure (from IFU Rev. 2025 01)

1 Focus on the specimen using a dry objective lens (×40), making sure that the specimen is central in the view.
2 Move the dry objective to one side and place a drop of Immersion Oil on top of the specimen. Move the oil immersion lens into place, ensuring that it makes contact with the oil drop.
3 View the specimen, making any fine adjustments to obtain the best image.
4 After use it is important to clean the oil from the lens using a soft tissue.

Limitations (from IFU Rev. 2025 01)

▶ Only experienced personnel should carry out the interpretation of stained slides.
▶ Read prepared slides as soon as possible after staining. Failure to do so may affect the results.
▶ Immersion Oil has an optimum refractive index at 23°C. While the product will remain stable if stored between 15°C and 25°C, samples will be visualised most clearly if the oil is stored at 23°C.
▶ Microbial contamination may decrease the accuracy of the staining.
▶ Do not use beyond the stated expiration date.

QC Requirement

Internal quality control of the Immersion Oil must be performed regularly on known reference material. The Pro-Slide™ range of quality control slides is available from Pro-Lab for this purpose. (IFU Rev. 2025 01)

Frequently Asked Questions

Yes. PL.396 is explicitly formulated without Dibutyl Phthalate (DBP) and is described in the IFU as non-teratogenic. DBP is restricted under EU REACH Annex XVII (effective July 2020) as a Reproductive Toxicant Category 1B. PL.396 eliminates this occupational hazard. (Source: IFU Rev. 2025 01; ECHA REACH Annex XVII)

Yes. Pro-Lab PL.396 carries CE marking as an In Vitro Diagnostic medical device (IVD symbol present on IFU Rev. 2025 01). CE/IVD documentation is available for laboratory accreditation files including ISO 15189, CAP, and CLIA. (Source: IFU Rev. 2025 01)

Store PL.396 in its original container at 15–25°C. For best image clarity, allow the oil to reach 23°C before use — this is the temperature at which the refractive index is optimised. (Source: IFU Rev. 2025 01)

(1) Focus on the specimen using a dry objective lens (×40), keeping the specimen centred in the view. (2) Move the dry objective aside and place a drop of Immersion Oil on top of the specimen; move the oil immersion lens into place ensuring contact with the oil drop. (3) View the specimen and make fine adjustments for the best image. (4) After use, clean the oil from the lens using a soft tissue. (Source: IFU Rev. 2025 01, Procedure section)

PL.396 produces no residual fluorescence and is stated as suitable for both light and fluorescence microscopy. For fluorescence applications (e.g., AFB auramine-rhodamine staining), confirm oil is at 23°C for optimal refractive index performance. (Source: pro-lab.com product page)

PL.396 should not be used beyond the expiry date printed on the product label. Slides should be read as soon as possible after staining — delay may affect results. Only experienced personnel should carry out interpretation of stained slides. Microbial contamination may decrease accuracy. Dispose of contents/container per local regulations. (Source: IFU Rev. 2025 01)

PL.396 (50ml, $39.99) is $12.81 less per bottle than Nikon Type N MXA22203 (50ml, $52.80). PL.396 is additionally DBP-free and CE/IVD marked — attributes Nikon Type N does not carry. (Source: Nikon Type N pricing — spectraservices.com April 2026; Pro-Lab pricing — pro-lab-direct.com)

Yes. Internal quality control must be performed regularly on known reference material. The Pro-Slide™ range of quality control slides is available from Pro-Lab for this purpose. (Source: IFU Rev. 2025 01, Quality Control section)

Immersion Oil DBP-Free 50ml — CE/IVD Certified for Clinical Microscopy