IVD reagents
IVD reagents are the kits, calibrators and controls used with analysers or manual methods to test patient samples. Laboratories buy them continuously for chemistry, haematology, immunoassay, coagulation and molecular testing.
Common types
- Clinical chemistry reagents: liquid or lyophilised kits for photometric tests.
- Immunoassay reagents: antibody based kits for hormones and markers.
- Haematology reagents: diluents, lysing agents and cleaners for cell counters.
- Molecular assay kits: primers, probes and master mixes for PCR testing.
- Calibrators and quality controls: materials with known values for checking results.
What to tell us when you ask for a quotation
- Analyser model the reagents must work with
- Test names and pack sizes
- Shelf life at delivery and on-board stability
- Storage and shipping temperature
- Calibrator and control availability
- Language of the insert and labels
- Quantity, destination country and the delivery terms you want (for example EXW, FOB or CIF).
Documents to ask for
Buyers ask for CE marking under the EU IVDR or the destination country's IVD registration for each kit, ISO 13485 for the maker, and the instructions for use and certificate of analysis for each lot.
Certificates and registrations belong to the product and its manufacturer. We check them with you against the rules of your market before any order.
How much shelf life should remain at delivery?
Buyers often specify a minimum remaining shelf life, such as two thirds of total shelf life, in the purchase order. This avoids receiving kits that expire before they can be used.
Send us the specification and quantity. We compare manufacturers in China and reply with options, lead times and the documents that come with each product. NJMC sources and checks; it does not manufacture.