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OEM and private label IVD manufacturing

Your label. Our line.

Reckon Diagnostics manufactures in vitro diagnostics under other companies’ brands in Vadodara, India, under its ISO 13485:2016 certified quality management system. Eight formats, from a finished kit in your carton to powder bulk you dissolve in your own market.

WHAT WE MAKE FOR YOU

Finished kits under your brand, semi-finished kits, filled unlabeled vials, uncut rapid test sheets, bulk supply, a DIY format, and reagent concentrates at 2x to 10x for local fill. Powder bulk that dissolves to ready-to-use reagent where liquid logistics fail.

FINISHED KITS UNCUT SHEETS CONCENTRATES 2X-10X POWDER BULK
Discuss a programme
OEM production
8Formats, from finished kit to powder bulk
10xStrongest concentrate: 1 litre shipped makes 10
152Stock codes in Reckon’s own catalogue
1989Manufacturing in Vadodara since

Eight formats.

How far we take the product is up to you. The further we take it, the less you need locally; the less we take it, the less freight you pay for.

  • Finished kitsFilled, labelled and cartoned under your brand, ready to sell when it lands.
  • Semi-finished kitsTaken to an agreed stage here and completed by you in your own facility.
  • Filled unlabeled vialsClinical chemistry and serology reagents filled and sealed without labels, for you to label locally.
  • Uncut rapid test sheetsTest sheets before cutting and assembly, for a partner who cuts them into strips and assembles cassettes locally.
  • Bulk OEM supplyProduct supplied in bulk, with quantities and packing agreed on the quotation.
  • DIY formatReckon’s own do-it-yourself format. What it includes for your assay is set out on the quotation.
  • Concentrates, 2x to 10xReagent at two to ten times working strength, diluted and filled in your market. At 10x, one litre shipped makes ten.
  • Powder bulkDry reagent that dissolves to ready-to-use, for routes where shipping liquid is the problem.

Questions buyers ask.

What can Reckon manufacture under my brand?

Eight formats: finished kits packed under your brand, semi-finished kits you complete, filled unlabeled vials of clinical chemistry and serology reagents, uncut rapid test sheets, bulk OEM supply, a DIY format, reagent concentrates at 2x to 10x working strength, and powder bulk that dissolves to ready-to-use reagent.

What do you need from me to quote?

Five things: the assay and format, the pack size, the annual volume, the market it ships to, and whether you need regulatory documentation for that market. Send what you have and we will tell you what is missing.

Is private-label product made to the same standard as Reckon’s own?

Yes. It is made under the same ISO 13485:2016 quality management, and each batch is QC-tested against reference standards and released in Vadodara before it is packed.

Why ship a concentrate instead of finished reagent?

Freight. A 10x concentrate makes ten times its volume of working reagent once diluted locally, so 90% less liquid travels; a 2x concentrate halves it. Powder bulk removes the liquid altogether, for routes where shipping liquid is the problem.

What documents come with an OEM programme?

Datasheets per stock code and the ISO 13485:2016 certificate. Which other documents your market needs is settled at the quotation.

What are the minimum order quantities, lead times and capacity?

They depend on the format and are agreed on the quotation.

I want Reckon-branded product, not my own brand. Is this the right page?

No. That is an export or distribution order, and the exports page covers it. Reckon ships its own brand to distributors in more than 25 countries.

Start a programme.

Send the assay, the format, the volume and the market. We reply from Vadodara with a quotation and a list of the documents your registration will need.

OEM and export: Rehan, rehan@reckondiagnostics.com, +91 91374 54615