Certificate: ISO 13485, CE
Shelf Life:2 years
Test item: influenza A virus, influenza B virus antigens and SARS-Cov-2
OEM/ODM:Accept
MOQ: if you take our Recare brand, 1,000 tests,
or we can custom produce for your brand, MOQ 10,000 tests is required.
ivd manufacturer flu test teste rapide at home swab saliva test

Utilizing high-affinity monoclonal–colloidal gold conjugates, this one-step lateral-flow immunoassay simultaneously detects influenza A, influenza B and SARS-CoV-2 nucleocapsid antigens in a single anterior-nasal swab. Clinical sensitivity ≥ 99 % and specificity ≥ 99 % for each target are achieved within 15 minutes, with distinct red bands at A, B and SARS-2 test lines plus control. The flu test is supplied as a tropical-stable, 24-month shelf-life individual pouch containing cassette, buffer, sterile swab and multilingual IFU, and is immediately ready for pharmacy self-testing, clinic triage or travel clearance; OEM private-label cassette, foil and box are available on request.

Influenza A/B & SARS-CoV-2 Combo Rapid Test Cassette Components
One kit contains the complete test kit:
1. Aluminum foil pouch containing one test kit with desiccant
2. Instructions for use
3. Swab
4. Buffer

Packing method:
1 whole test kit in a box, 400 boxes in a shipping carton.
You can buy our Recare brand, MOQ 1000 tests, and we can accept OEM produce for your brand, print your design on foil/box, print your logo on the cassette...

Questions & Answers:
Q1:Provide free sample?
A1:You can have some at home rapid test samples, you need to pay for samples and shipping cost.
Q2:What’s your lead time for IVD raw materials?
A2: If you need 1,000 tests, 15 days, if you need 10,000 tests, 30 days.
Q3:What services can we provide for IVD raw materials?
A3:Antigen & antibody provide limited technology support for conjugate and capture. Also, we provide professional online service for rapid test and swab test after-sales.
Q4:How is your factory doing in terms of ivd manufacturer quality control?
A4:We have CE certification and ISO13485 certification, and for all the production process we strictly comply with the relevant requirements and laws of the government. Also, Always a pre-production sample before mass saliva rapid test production and final inspection before delivery.