ISO 13485 Certified LAMP Validated

Pure Pro-Spin RNA Extraction Kit — ISO 13485-Certified, LAMP-Validated

Same silica-membrane technology as Qiagen RNeasy. Built under ISO 13485 quality standards. Validated for LAMP, real-time PCR, and RT-PCR. Order direct — no distributor markup.

Pure Pro-Spin RNA Extraction Kit PLM-2004 — silica membrane spin column kit
verified

Catalog #

PLM-2004 · 50 Preps

check_circleISO 13485 Certified — NQA/ANAB Pro-Lab Diagnostics USA PLM-2004 50 Preps check_circleRNase QC on Every Lot

PLACEHOLDER: Request testimonials from top 3 existing Pro-Lab molecular accounts — Day 1 action per marketing-plan.md §1.4. "As used at" logos pending account identification from CRM.

Clinical Performance. Regulatory Confidence.

description

ISO 13485 Certified

Quality certification your CAP accreditation team recognizes. Manufactured under NQA/ANAB accredited ISO 13485 quality management.

ISO 13485 logo — pro-lab-direct.com — Confirmed

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LAMP Validated

Specifically validated for LAMP, RT-PCR, and real-time PCR — covering the three dominant molecular diagnostic workflows in clinical labs today.

PLM-2004 product page — Claimed

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RNase QC

All buffer components are individually QC-checked for RNase activity before lot release — eliminating the kit as a variable when troubleshooting yield issues.

Product page — Claimed

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Protocol Compatible

Same silica-membrane spin column principle as Qiagen RNeasy. Labs validated on Qiagen can evaluate Pro-Spin with a bridging study, not a full re-validation.

Alkan et al., Anal Biochem 2017 (PMC5503482) — Corroborated

Built for Every Role in Your Lab

ISO 13485-Certified, LAMP-Validated RNA Extraction — Direct from Pro-Lab Diagnostics

RNA reagent costs are one of the fastest-growing line items in molecular lab supply budgets. Pure Pro-Spin delivers the silica-membrane purity your LAMP and RT-PCR workflows require — manufactured under ISO 13485 certification from Pro-Lab Diagnostics, a brand clinical labs have relied on for decades.

  • check_circleISO 13485 certified under NQA/ANAB — documentation available for CAP binders and pre-analytical reagent qualification
  • check_circleValidated for LAMP, real-time PCR, and RT-PCR — compatible with current molecular diagnostic workflows
  • check_circleSilica membrane technology identical to Qiagen RNeasy — bridging study typically requires 10 side-by-side samples, not a full re-validation

Common Questions from Lab Directors

Our lab is already validated on Qiagen RNeasy. How much re-validation is required?

Pro-Spin uses the same silica-membrane principle — existing LAMP and RT-PCR protocols are directly compatible. A bridging study typically requires 10 side-by-side samples, not a full re-validation program.

How does ISO 13485 certification satisfy CAP requirements for pre-analytical reagents?

ISO 13485 covers design controls, process controls, and traceability at every manufacturing step. Pro-Lab's ISO 13485 certification (NQA/ANAB) documentation is available on request for your CAP binder.

Compatible with Your Current LAMP Workflow — No Protocol Rewrite Required

Lab Managers running molecular workflows know the cost of failed extractions: wasted time, wasted assay reagents, and results that can't be reported. Pure Pro-Spin is built on proven silica-membrane technology, ISO 13485 certified, and validated for LAMP, real-time PCR, and RT-PCR. All buffer components are QC-tested for RNase activity — the most common source of RNA extraction failure.

  • check_circleSilica membrane spin column — same lysis-bind-wash-elute principle as Qiagen RNeasy; confirm parameters against Pro-Spin IFU before SOP update
  • check_circleISO 13485 certified — lot release criteria, QC records, and traceability documented at every manufacturing step
  • check_circleCertificate of Analysis available for every lot — contact us with your lot number

Evaluation Protocol

1.Run 10 samples in parallel — 5 with Pro-Spin, 5 with your current kit — on your active LAMP or RT-PCR assay
2.Compare Ct values (RT-PCR) or amplification time (LAMP); measure A260/A280 if a spectrophotometer is available
3.Document results — this is your bridging data. One bench day, not weeks.

Reliable RNA, Every Run — Without the Troubleshooting

A failed RNA extraction costs you a run, a set of controls, and a batch of samples that must be re-collected. Pure Pro-Spin uses proven silica-membrane spin column technology — the same principle as the kits your bench already runs — with all buffer components individually QC-checked for RNase contamination before release. There is no new protocol to learn.

  • check_circleAll buffer components QC-checked for RNase contamination before lot release — prevents the most common bench failure
  • check_circleStandard silica-spin workflow — lysis, bind, wash, elute — no new technique; same troubleshooting logic as Qiagen RNeasy
  • check_circleValidated for LAMP, real-time PCR, and RT-PCR

How It Works

1Lyse — Add sample to lysis buffer. Mix. RNA is released; RNases are inactivated.
2Bind — Transfer lysate to spin column. Centrifuge. RNA binds to the silica membrane.
3Wash — Centrifuge through wash buffers. Proteins, lipids, and inhibitors pass through.
4Elute — Add elution buffer. Centrifuge. Collect purified RNA.

Confirm exact centrifuge speeds and volumes from IFU when received.

PLM-2004 — ISO 13485-Certified. Direct Ordering. Net 30 Available.

Pure Pro-Spin RNA Extraction Kit is available for direct purchase from Pro-Lab Diagnostics USA — same account as your existing TestOxidase, Mucolyse, and Microbank orders. ISO 13485 certified. 50 preps per kit. Net 30 billing terms available for qualifying accounts.

  • check_circleDirect ordering at pro-lab-direct.com — same account as existing Pro-Lab Diagnostics products
  • check_circleNet 30 terms available for qualifying accounts
  • check_circleISO 13485 certificate, W-9, COI, and supplier questionnaire responses available on request

Ordering Information

Product NamePure Pro-Spin RNA Extraction Kit
Catalog #PLM-2004
Pack Size50 preps
PriceContact for pricing — info@pro-lab.com
Payment TermsNet 30 (qualifying) / Credit card
DistributorFisher / VWR listing in development

Pure Pro-Spin vs. Qiagen RNeasy Mini Kit

FeaturePure Pro-Spin (PLM-2004)Qiagen RNeasy Mini Kit
Validated for LAMP✓ Yes — stated on product page⚠ Not specifically stated (2026-04)
ISO 13485 Certified✓ NQA/ANAB accredited✓ ISO 13485 compliant
TechnologySilica membrane spin columnSilica membrane spin column
Price (50 preps)Contact for pricing~$432 (Fisher Scientific, 2026-04)
Direct ordering✓ pro-lab-direct.com · Net 30Via Fisher/VWR/direct
RNase QC stated on product page✓ Prominently stated — all buffers QC-testedNot prominently stated on product page (Qiagen.com, April 2026)

Qiagen price: Fisher Scientific catalog, April 2026. LAMP validation comparison: both product pages, April 2026.

Technical Specifications

SpecificationValue
Catalog numberPLM-2004
TechnologySilica-membrane spin column
Validated applicationsLAMP, real-time PCR (qRT-PCR), RT-PCR
CLIA complexityN/A — sample preparation reagent, not a diagnostic assay
Specimen typeVarious sample types — confirm complete list from IFU
Extraction time~15–30 min typical (confirm from IFU)
Instrument requiredMicrocentrifuge ≥12,000 × g — not included (confirm speed from IFU)
StorageRoom temperature (except Grinding Buffer: 2–8°C). Do not freeze any components.
Shelf lifeAt least 12 months under recommended storage conditions
Yield (preps per kit)50 preps
ISO certificationISO 13485 — NQA / ANAB
ManufacturerPro-Lab Diagnostics USA

Storage and shelf life sourced from IFU PLM-2004 ver-20180706. SDS pending — contact info@pro-lab.com to request documentation.

Frequently Asked Questions

Yes. PLM-2004 is specifically validated for Loop Mediated Isothermal Amplification (LAMP), real-time PCR, and RT-PCR. [Claimed — PLM-2004 product page]
Yes. Pure Pro-Spin RNA Extraction Kit is manufactured under an ISO 13485-certified quality management system, accredited by NQA under ANAB. ISO 13485 documentation is available on request for CAP binders and supplier qualification files. [Confirmed — ISO 13485 logo, product page]
Yes. Both use silica-membrane spin column technology — the same principle: chaotropic lysis buffer releases RNA, which binds selectively to the silica membrane; contaminants are washed away; pure RNA is eluted in low-salt buffer. Labs validated on Qiagen RNeasy can evaluate Pro-Spin with a bridging study rather than a full re-validation. [Corroborated — Alkan et al., Anal Biochem 2017 (PMC5503482)]
PLM-2004 contains 50 preps per kit. [Confirmed — product page]
A microcentrifuge capable of at least 12,000 × g is required but not included. No specialized automation equipment is needed — this is a manual bench-top spin-column kit. Confirm exact centrifuge speed from IFU when received. [Inferred from kit class; confirm from IFU]
Certain sample types require specialized protocols with any silica spin column kit — including formalin-fixed paraffin-embedded (FFPE) samples, samples with very high lipid content, and very low-input samples that may require carrier RNA addition. Confirm your specific sample type is supported by reviewing the IFU before use. [Corroborated — standard limitations for silica-spin column kit class; confirm from IFU]
RNase contamination and incorrect centrifuge speed are the two most common causes of low or zero yield. Pure Pro-Spin buffer components are individually QC-tested for RNase activity before lot release — eliminating the kit as a variable. If yield is low, verify centrifuge speed and sample input integrity as first troubleshooting steps. [Claimed — product page (RNase QC); Corroborated — standard silica-spin troubleshooting]

Ready to Evaluate Pure Pro-Spin?

Product & Regulatory Information

Regulatory status: For Research Use Only. Not intended for the diagnosis, prevention, or treatment of disease. Source: IFU PLM-2004 ver-20180706.

Principle: Total RNA isolation via silica-membrane spin column. Lysis buffer denatures and lyses cells, inactivating RNases and releasing RNA. RNA binds selectively to the silica gel membrane under chaotropic buffer conditions. Contaminants are removed by wash buffers. Pure RNA is eluted in low-salt buffer. [Corroborated — product page description + established silica-membrane chemistry]

RNase QC: All buffer components are quality control checked for RNase contamination. [Claimed — product page] Per-run QC requirements (controls, frequency) — confirm from IFU when received.

Hazard information: [FLAG — SDS not yet received. GHS pictograms, signal word, hazard statements, PPE requirements, and disposal classification to be added upon SDS acquisition. Request from info@pro-lab.com.]

IFU and SDS: Instructions for use and safety data sheet available on request. Contact info@pro-lab.com or download from the product page at pro-lab-direct.com/product-p/plm-2004.htm.