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Molecular Diagnostic Raw Materials for IVD Assay Development

DNA polymerases, reverse transcriptases, UNG/UDG, qPCR and RT-qPCR master mixes, LAMP reagents, nucleotides and lyoprotectants for IVD kit development and manufacturing. Most products are offered in standard, glycerol-free, lyo-ready and low-residual-DNA identities on one product page.

PCR reaction tubes, 8-tube strips and an amber enzyme vial
44
products for assay development and manufacturing
4
formulation identities: standard, glycerol-free, lyo-ready, low-residual DNA
18 months
room-temperature stability data on lyophilized mixes
ISO 13485
SGS-certified quality system
From raw material to kit

Where each category sits in an IVD kit build

Choose the enzyme, then the mix, then the formulation identity, then the format.

1
EnzymesPolymerase, RT, UNG
2
Master mixqPCR, RT-qPCR, LAMP
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IdentityStandard · Glycerol-free · Lyo-ready · Low-residual
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LyophilizationBeads, strips, plates, vials
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Your kitRelease with COA, SDS, TDS
Lyophilization service

From lyo-ready mix to freeze-dried kit

Formulation assessment, cycle development, pilot lots and production in beads, 8-tube strips, plates and vials. 18-month room-temperature data and shipping stress data are published on the service page. No minimum order.

See the lyophilization service →

Quality

ISO 13485 certified, released on four tests

Every lyophilized lot is released on water content, amplification efficiency, sensitivity and stability, with lot-specific COA, SDS and TDS. Certificate CN24/00007233 (SGS).

Quality system and production environment →

Developing an IVD kit?

Send the assay brief. We propose the enzyme, mix and formulation identity, and evaluation samples.

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