Is Mucolyse IVD-labeled?

Yes. Mucolyse™ (PL.701) is labeled 'For In Vitro Diagnostic Use Only' and manufactured under an ISO 13485:2016 MDSAP-certified quality system. It is CE marked under the EU IVD Directive. Unlike Sputolysin (MilliporeSigma), which is a Calbiochem biochemical reagent with no IVD claim, Mucolyse is fully documented for CLIA/CAP-inspected labs.

How does Mucolyse compare to Sputolysin?

Both use dithiothreitol (DTT). Key differences: Mucolyse is IVD-labeled and ISO 13485:2016 MDSAP certified; Sputolysin is a research-grade biochemical reagent with no IVD claim. Mucolyse is lyophilized (stable until expiry at 2–8°C, no daily prep); Sputolysin is liquid with 48-hour post-reconstitution stability requiring daily fresh preparation. Mucolyse costs approximately $11.92/vial vs. ~$28.50/vial for Sputolysin at 20-vial set pricing.

Does DTT inhibit Haemophilus influenzae?

Yes — DTT at recommended concentrations inhibits Haemophilus influenzae growth. This is a known limitation shared by all DTT-based sputum processing reagents. For specimens where H. influenzae is a target pathogen, perform parallel direct plating alongside DTT-processed specimens. Source: Hammerschlag et al. J Clin Microbiol. 1980;11(6):552–557. PMID 6776135.

How do you reconstitute Mucolyse?

Add 10 mL sterile distilled water to the lyophilized vial and agitate gently until dissolved. Transfer to 90 mL sterile distilled water — final 100 mL, pH 7.0. Overlay sputum 1:1, vortex 30 seconds, stand 15 minutes. Ready for culture, smear, or molecular testing.

What is the Fisher Scientific catalog number for Mucolyse?

Fisher Scientific catalog number 23265635. Medline item number Z05-PF283411. No new vendor approval required for labs already purchasing through Fisher.

Is Mucolyse safe to ship by air?

Yes. Mucolyse is not regulated as a hazardous material under any transport mode — not assigned a UN number, not classified under ADR/RID, IMDG, or IATA. Cold-pack packaging is required to maintain 2–8°C transit temperature. No hazmat surcharge applies. Source: SDS PL.701 v4, 2017-05-15, Section 14.

Mucolyse™ Sputum Digestant IVD | DTT

Name: Mucolyse™ PL.701
Brand: Mucolyse
SKU: PL.701
Price: 119.19 USD
Availability: InStock

Why Clinical Labs Choose Mucolyse

Same DTT chemistry as competitors. Different in every way that matters to a regulated lab.

security

IVD Compliance

The only lyophilized, IVD-labeled DTT sputum digestant with ISO 13485:2016 MDSAP certification — audit-ready documentation for every CAP/CLIA inspection.

IFU Rev. 2023-04 | ISO 13485:2016

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No Daily Prep

Lyophilized and stable at 2–8°C until expiry — no daily reconstitution, no 48-hour clock, no wasted batch. Unlike Sputolysin and Sputasol, which require fresh preparation every day.

IFU Rev. 2023-04 Storage section

analytics

Superior Mucolysis

DTT's dithiol structure cleaves mucoprotein disulfide bonds more completely than monothiol NAC/NALC reagents — converting viscous sputum into a homogeneous liquid for consistent culture, smear, and molecular testing.

IFU PL.701 Rev. 2023-04, Principle of Test

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Molecular Ready

Independent 2025 study: DTT achieves 100% detection sensitivity for respiratory pathogens in sputum multiplex PCR — superior to proteinase K (87.5%, P<0.05).

Chang et al. BMC Microbiol. 2025 — PMID 40263996

Tailored for Your Role

Your Sputum Processing Reagent Must Be IVD-Labeled. Is Yours?

Most labs use Sputolysin (MilliporeSigma) for sputum processing. Sputolysin is an effective DTT reagent — but it is explicitly a Calbiochem biochemical: no IVD claim, no ISO 13485. In a CLIA or CAP-inspected lab, using a research-grade reagent for diagnostic specimen processing is a documentable compliance gap. Mucolyse closes it: same DTT chemistry, IVD-labeled, ISO 13485:2016 MDSAP certified, available through Fisher Scientific (Cat. 23265635).

check_circle IVD-labeled and ISO 13485:2016 MDSAP certified — audit-ready documentation for every CAP/CLIA inspection.
check_circle CE IVD marked — compliant with EU IVD Directive for international or multi-site labs.
check_circle Stable supply via Fisher Scientific (Cat. 23265635) and Medline (Z05-PF283411).

Stop Reconstituting Your Sputum Reagent Every Day

If your lab uses Sputolysin or Sputasol, someone is preparing a fresh working solution every day — or writing off a batch that degraded before it was used. Mucolyse is lyophilized and stable at 2–8°C until expiry. Reconstitute when you need it. Same DTT chemistry, same 1:1 ratio, same 15-minute processing time — without the daily preparation overhead and 48-hour expiry constraint.

check_circle Lyophilized — stable at 2–8°C until expiry; no daily reconstitution required.
check_circle Liquid DTT competitors (Sputolysin, Sputasol) expire 48 hours after reconstitution — daily preparation required.
check_circle pH 7.0 per vial, individually formulated — consistent batch-to-batch without in-house pH adjustment.

Simple Sputum Liquefaction. 15 Minutes. Consistent Results.

Mucolyse is a lyophilized dithiothreitol (DTT) sputum digestant. Each vial reconstitutes to 100 mL of buffered working solution (pH 7.0). Overlay your sputum sample 1:1, vortex 30 seconds, stand 15 minutes — homogenized and ready for culture, smear, or molecular testing. DTT does not affect pathogen morphology, growth, or fluorescent antibody staining.

Procedure (IFU PL.701 Rev. 2023-04)

Reconstitution:

Aseptically add 10 mL sterile distilled water to the lyophilized vial.
Close the vial and gently agitate until completely reconstituted (solution is clear and free from visible particulate matter).
Add the contents of the vial to 90 mL sterile distilled water — final volume 100 mL, pH 7.0.

Specimen Processing:

Overlay sputum sample with an equal volume of Mucolyse working solution (1:1 ratio).
Vortex the sputum for 30 seconds.
Allow the mixture to stand at room temperature for 15 minutes.
Proceed to downstream analyses (culture, smear, or molecular testing).

Note: Prolonged standing will not inhibit floral multiplication.

⚠ Limitation: DTT at recommended concentrations inhibits Haemophilus influenzae growth. For specimens where H. influenzae is a target pathogen, perform parallel direct plating. Hammerschlag et al. J Clin Microbiol. 1980;11(6):552–557. PMID 6776135

Order Mucolyse PL.701 Through Your Existing Channels

Mucolyse PL.701 is available through Fisher Scientific (Cat. 23265635) and Medline (Cat. Z05-PF283411) — no new vendor onboarding required. Order directly from Pro-Lab Direct for the best pricing. IVD-labeled and ISO 13485:2016 MDSAP certified; full documentation available for formulary or vendor approval.

check_circle Fisher Scientific Cat. 23265635 — available through existing Fisher accounts.
check_circle Medline Cat. Z05-PF283411 — available through Medline purchasing.
check_circle Single global SKU (PL.701) — no regional variant confusion across distributors.
local_shipping Ships with cold pack. Not classified as hazardous material under any transport mode (ADR/IATA/IMDG). No hazmat surcharge.

Mucolyse™ vs. Sputolysin®

Same DTT chemistry. Different in every way that matters to an inspected lab.

Feature	Mucolyse™ PL.701	Sputolysin® (Cat. 560000)	Source
IVD Labeled	✅ Yes	❌ No — research reagent	IFU vs. Sigma product page
ISO 13485:2016 MDSAP	✅ Yes	❌ Not confirmed	Pro-Lab listing vs. Sigma
CE IVD Mark	✅ Yes	❌ Not IVD CE marked	IFU symbol legend
Format	✅ Lyophilized (stable until expiry)	⚠️ Liquid concentrate (48h stability)	IFU vs. Sputolysin data
Daily Prep Required	✅ No	⚠️ Yes — fresh daily reconstitution	IFU vs. competitor data
CLIA/CAP Compliant	✅ IVD-labeled = defensible	⚠️ Research reagent = compliance exposure	Regulatory classification
Available via Fisher	✅ Cat. 23265635	✅ Cat. 56-000-010ML	Fisher website
Price per Vial	~$11.92 ($119.19/10-vial box)	~$28.50 (20-vial set rate, $570.50/set)	pro-lab-direct.com; Fisher listing

Product Specifications

Catalog Number	PL.701
Active Ingredient	Dithiothreitol (DTT) 100 mg/vial
Format	Lyophilized (white solid pellet)
Pack Size	10 vials per box
Working Volume	100 mL per vial
Working pH	7.0
Processing Time	15 minutes at room temperature
Storage	2–8°C until expiry date on label
Specimen Type	Sputum (spontaneous or induced)
IVD Labeled	Yes — For In Vitro Diagnostic Use Only
ISO 13485	ISO 13485:2016 MDSAP Certified
CE IVD	Yes — CE IVD Marked
Fisher #	23265635
Medline #	Z05-PF283411
EC REP	Advena Ltd., Tower Business Centre, 2nd Flr., Tower Street, Swatar, BKR 4013 Malta

Safety Information (SDS PL.701 v4)

Signal Word: WARNING

GHS07 — Exclamation Mark Pictogram

H315Causes skin irritation.

H319Causes serious eye irritation.

PPE Required

visibility Chemical splash goggles
back_hand Chemical-resistant, impervious gloves
clean_hands Wash hands thoroughly after handling

Disposal

Dispose via licensed waste disposal contractor in compliance with environmental protection and waste disposal legislation. Product may meet criteria for hazardous waste.

SDS PL.701 v4, 2017-05-15, Section 13

download Download SDS (EU/UK v4, 2017-05-15)

US-format OSHA HazCom 2012 SDS available on request — contact support@pro-lab.com

Frequently Asked Questions

Compliance, procedure, and sourcing questions answered.

Yes. Mucolyse™ (PL.701) is labeled "For In Vitro Diagnostic Use Only" and manufactured under an ISO 13485:2016 MDSAP-certified quality system. It is CE marked under the EU IVD Directive. This makes it suitable for use in CLIA and CAP-inspected clinical microbiology laboratories — unlike research-grade DTT reagents (such as Sputolysin by MilliporeSigma) which carry no IVD claim. Source: IFU PL.701 Rev. 2023-04; pro-lab-direct.com

Both products contain dithiothreitol (DTT) as the active mucolytic agent. The key differences: Mucolyse is IVD-labeled and ISO 13485:2016 MDSAP certified; Sputolysin is a research-grade Calbiochem biochemical reagent with no IVD claim. Mucolyse is lyophilized (white solid pellet, stable until expiry at 2–8°C); Sputolysin is a liquid concentrate with a 48-hour post-reconstitution stability window requiring daily fresh preparation. Mucolyse costs approximately $11.92/vial vs. ~$28.50/vial for Sputolysin at 20-vial set pricing. Source: IFU PL.701 Rev. 2023-04; Sigma-Aldrich Sputolysin product page

Yes — DTT at recommended concentrations inhibits Haemophilus influenzae growth. This is a known, accepted limitation of all DTT-based sputum processing reagents, including Sputolysin and Sputasol. For specimens where H. influenzae is a priority pathogen (COPD exacerbations, cystic fibrosis, pediatric respiratory infections), parallel direct plating should be performed alongside DTT-processed specimens. DTT does not inhibit Pseudomonas aeruginosa, Staphylococcus aureus, or most other respiratory pathogens. Source: Hammerschlag et al. J Clin Microbiol. 1980;11(6):552–557. PMID 6776135

Yes. DTT-based sputum liquefaction for CF respiratory samples is supported by updated ASM and Cystic Fibrosis Foundation guidance. Note the H. influenzae inhibition limitation; the 2024 guidance acknowledges this and recommends plating DTT-processed CF specimens within 3 hours of liquefaction. Source: Saiman L, et al. Clin Microbiol Rev. 2024;37(3):e0021521. PMID 39158301

Add 10 mL sterile distilled water to the lyophilized vial and agitate gently until fully dissolved. Transfer to 90 mL sterile distilled water — final volume 100 mL, pH 7.0. Overlay sputum 1:1 with working solution, vortex 30 seconds, stand at room temperature for 15 minutes. Sample is ready for downstream culture, smear, or molecular testing. Source: IFU PL.701 Rev. 2023-04 Procedure section

Yes. An independent 2025 study demonstrated DTT achieves 100% detection sensitivity for respiratory pathogens in sputum for multiplex PCR — statistically superior to proteinase K (87.5%, P<0.05), supporting Mucolyse as a validated pre-processing step for GeneXpert, BioFire, and other molecular platforms. Source: Chang Y, et al. BMC Microbiol. 2025;25:233. PMID 40263996

IFU (Rev. 2023-04), SDS (EU/UK edition v4, 15/05/2017; US format available on request), and ISO 13485:2016 MDSAP certification documentation are all available. Contact support@pro-lab.com or use the "Request Documentation" button on this page. Source: IFU PL.701 Rev. 2023-04; SDS PL.701 v4 2017-05-15

Yes. Mucolyse is not regulated as a hazardous material under any transport mode — it is not assigned a UN number and carries no transport hazard classification under ADR/RID, IMDG, or IATA. Cold-pack packaging is required to maintain 2–8°C transit temperature. No hazmat surcharge applies. Source: SDS PL.701 v4, 2017-05-15, Section 14 — all modes "Not regulated"

Your Sputum Processing Reagent Must Be IVD-Labeled. Is Yours?