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| Product Name | In Vitro Diagnostic (IVD) Grade Oligonucleotide Synthesis Service |
| Catalog No. | PRIPRO-0024 |
| Description | A specialized oligonucleotide synthesis service producing primers and probes for in vitro diagnostic (IVD) assay manufacturing. IVD-grade oligos are manufactured under stringent quality management systems in compliance with ISO 13485:2016 (Medical Devices — Quality Management Systems). This service addresses the unique requirements of diagnostic kit developers: full material traceability from raw phosphoramidites to finished product, validated manufacturing processes with documented change control, enhanced quality control including bioburden and endotoxin testing, stability studies at recommended storage conditions, and comprehensive documentation packages suitable for regulatory submissions (NMPA, FDA, CE-IVDR). Products are supplied with certificates of analysis, certificates of conformance, and device master record (DMR) documentation. Custom fill/finish and lyophilization into diagnostic kit formats are available. |
| Intended Use | Specifically designed for incorporation into registered in vitro diagnostic (IVD) medical device kits, including PCR-based infectious disease detection assays, oncology companion diagnostics, genetic testing panels, pharmacogenomic assays, and any regulated diagnostic product requiring oligonucleotide raw materials with full regulatory documentation. |
| Principle / Technology | Solid-phase phosphoramidite synthesis under ISO 13485 quality management system; all processes validated and documented per medical device regulatory requirements; full batch record maintained for each production lot |
| Detection Method | HPLC or PAGE purification; comprehensive QC including MS, purity, concentration, endotoxin (LAL), bioburden, heavy metals, residual solvents; stability indicating assays per ICH guidelines |
| Sample Type | Clinical specimens processed by the IVD kit; sample types defined by the intended use of the diagnostic assay (blood, swabs, urine, tissue, etc.) |
| Performance Range / Specifications | Primers 15–35 bases; probes 15–30 bases; scales from 100 nmol to multi-gram bulk; purity ≥95% by HPLC; endotoxin <0.1 EU/µg; bioburden <10 CFU/mL |
| Sensitivity / LOD | Performance specifications defined per customer IVD assay requirements; lot release testing includes functional performance verification; process capability (Cpk) analysis available |
| Specificity | Sequence-specific synthesis verified by MALDI-TOF MS; each lot released against customer-approved reference standard; no cross-reactivity with off-target sequences confirmed by BLAST analysis |
| Reaction Conditions / Protocol | Customer-specific protocols as defined in the IVD kit instructions for use (IFU); synthesis, purification, and QC aligned with customer-validated manufacturing procedure; dedicated production suite with line clearance between products |
| Components / Formulation | Custom oligonucleotide(s) manufactured to IVD specification; certificate of analysis; certificate of conformance; batch manufacturing record summary; stability study protocol and data as agreed |
| Storage Conditions | As specified in customer stability protocol; typically –20 °C ± 5 °C with continuous temperature monitoring |
| Shelf Life | Determined by customer stability study; initial shelf life assignment of 12–24 months typical, extendable with real-time stability data |
| Package Specifications | Customer-specified packaging: bulk bottles, pre-aliquoted tubes, lyophilized in kit plates or strips, or custom formats; labeling per IVD regulatory requirements (UDI-compatible) |
| Product Form | Lyophilized powder or concentrated solution per customer specification; custom formulation (buffer, excipients) available |
| Quality Control | ISO 13485-compliant QC: HPLC purity ≥95%; MALDI-TOF MS; concentration by A260; endotoxin (LAL) <0.1 EU/µg; bioburden <10 CFU/mL; heavy metals per USP <232>/<233>; residual solvents per USP <467>; stability indicating HPLC; functional performance per customer specification; retained samples for full shelf life. |
| Key Features | ISO 13485:2016 certified manufacturing facility; full material traceability to raw phosphoramidite lots; validated and locked manufacturing process with change control; DMR and DHR documentation; regulatory submission support (NMPA, FDA 510(k), CE-IVDR technical documentation); dedicated or segregated production lines; customer audits welcomed. |
| Purity | ≥95% by validated HPLC method; impurity profile characterized and controlled; reference standard program available |
| Concentration | Manufactured to customer target concentration ±10%; fill volume verified; concentration confirmed by validated A260 method with customer-approved extinction coefficient |
| Activity / Unit Definition | Functional performance verified by customer-approved lot release assay; PCR efficiency 90–110% and R² ≥0.98 per customer acceptance criteria; process capability Cpk ≥1.33 for critical quality attributes |
| Molecular Weight | Sequence-dependent; verified by MS for each lot; mass accuracy within customer specification (typically ±0.05%) |
| Source / Origin | Synthetic phosphoramidite chemistry; all raw materials from qualified and audited suppliers; supplier qualification dossiers maintained; no animal-derived materials unless specified |
| pH Range / Optimal pH | As per customer formulation; standard oligo stable pH 6.0–9.0; formulation pH verified at release and on stability |
| Shipping Conditions | Validated shipping configuration per customer stability protocol; options: ambient, cold pack (2–8 °C), or dry ice (–78 °C); temperature monitoring devices available; cold chain validation data provided |
| Expiration Date / Stability | Customer-specific stability program: real-time and accelerated conditions per ICH Q1A(R2); shelf life assigned based on real-time data; ongoing stability program with annual pull points |
| Regulatory / Compliance | ISO 13485:2016 certified; manufactured in compliance with FDA 21 CFR Part 820 (Quality System Regulation) principles; CE-IVDR 2017/746 compliant documentation package; NMPA registration support; GMP-compliant batch release; change notification agreement |
| Compatibility | Customer-specified compatibility: verified with customer's master mix, instrument platform, and sample matrix; compatibility study data provided; no changes to formulation without customer approval per change control agreement |
| Recommended Buffer System | Customer-specified or co-developed formulation; standard options: nuclease-free water, TE buffer, or custom buffer system; formulation validated for stability and performance |
| Application Notes / Precautions | A quality/technical agreement (QTA) is established before production. Customer-specific analytical methods are transferred and validated. Process validation (IQ/OQ/PQ) documentation provided. Retain samples stored for full shelf life plus one year. Annual product quality review (APQR) conducted. |
| Batch-to-Batch Consistency | Process validation demonstrating consistent quality across minimum three consecutive production lots; ongoing SPC monitoring of critical quality attributes; annual product quality review documenting continued process capability; change control process for any deviations |
For research use only, not for clinical use.
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