Medical Devices & Diagnostics · LP-209
COVID/Influenza antigen test Diagnostic test
Device / diagnostic development record. Review the proposed presentation and the professional reference information below.
Development record
- Portfolio reference
- LP-209Medical Devices & Diagnostics
- Product type
- COVID/Influenza antigen testDiagnostic test
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Product-type reference
Record identity and reference background.
- Portfolio reference
- LP-209
- Product type
- COVID/Influenza antigen test
- Device presentation
- Diagnostic test
- Configuration / specification
- Combo cassette
- Proposed pack
- Single-use pouch; carton 20/25
- Portfolio category
- Medical Devices & Diagnostics
About COVID/Influenza antigen test
A combined COVID-19 and influenza antigen test is an in vitro diagnostic device designed to detect specified viral antigens in an authorized specimen. The term combo does not establish which influenza targets, sample type, age range or setting the device supports. Antigen testing differs from nucleic-acid testing and has different sensitivity and interpretation considerations. This is a diagnostic catalogue entry, not a medicine or a confirmation of device authorization.
How to read this profile
Scientific information relates to the device or diagnostic type. It is not approved Luang Pharma labelling, a clinical recommendation, or evidence of equivalence to a referenced product. Multiple strengths or presentations represent separate proposed variants and must not be treated as interchangeable.
02 · Professional background
Scientific & clinical reference
Read the clinical context, selected safety considerations and presentation-specific information below.
Intended-use context
Testing decisions consider symptoms, timing, exposure and the consequence of an incorrect result. A negative antigen result does not necessarily exclude COVID-19 or influenza, especially when testing occurs outside the validated conditions. Follow-up or a different test may be appropriate under current local guidance. Performance must be established for each target, and a claim for one component cannot be transferred automatically to the other.
Important safety considerations
Poor sampling, incorrect timing, unsuitable specimens, degraded reagents or misreading can produce false results. Delayed care after a false-negative result can be clinically important in vulnerable patients. A positive result does not exclude co-infection or another cause of illness. Kit chemicals must not be swallowed or placed on the body. Used specimens and consumables need appropriate disposal, and any serious symptoms require clinical assessment regardless of the cassette result.
These are selected considerations, not a complete list. Use the current instructions or approved label for the exact authorised product and seek appropriate professional advice.
Presentation, handling and storage
The source lists a combination cassette and pack counts, without a named assay. Verify every target, approved specimen, user setting, read window, control requirements and component-specific sensitivity and specificity in the authorized instructions.
Store and use the complete kit only within its validated conditions. Observe the package expiry, reagent requirements and exact read window. Do not mix components or buffers from different kits or lots unless explicitly permitted, and do not reuse single-use devices.
Final composition, instructions, shelf life and storage conditions are not established by this portfolio entry. They must come from the controlled documentation for the specific product.
Points for professional review
Confirm device identity, destination authorization, target-level performance evidence and the local testing pathway. Publish only claims supported by the exact assay’s documentation.
03 · Product enquiry
Documentation & regulatory status
Evidence status
What is established — and what remains open
This record has received an editorial evidence-layer review. The review separates catalogue facts from unresolved product-specific fields and external context; it is not medical, regulatory or market-authorisation approval.
Layer 01
Controlled catalogue facts
- Device / diagnostic type
- COVID/Influenza antigen test
- Presentation
- Diagnostic test
- Catalogue configuration
- Combo cassette
- Catalogue pack
- Single-use pouch; carton 20/25
- Portfolio category
- Medical Devices & Diagnostics
Layer 02
Unresolved product-specific fields
- P024 — “COVID/Influenza antigen test” and “combo cassette” do not identify the manufacturer/model, specimen type, exact viral targets, reader format, intended-use setting, age range, read window or performance characteristics.
- No sensitivity, specificity, regulatory authorization, home-use status or equivalence to an FDA-authorized comparator test is inferred.
- Approved indication, patient eligibility and dosing or test interpretation are not established by this portfolio record.
- Registration/authorization, manufacturing or site status, supply availability, storage conditions and shelf life remain product- and market-specific evidence items.
Layer 03
Attributed external context
- FDA: marketing authorization of an at-home COVID-19/Flu A&B antigen combination testgovernment medical-device regulatory context
These references provide scientific or regulatory context only. They are not Luang Pharma product labelling, registration, manufacturing evidence, equivalence evidence or confirmation of supply.
Layer 04
Documents required to close the record
- Exact manufacturer/model specification and IFU establishing intended use, technical configuration, performance limits, accessories/compatibility, warnings, storage, shelf life and sterilization where applicable.
- Destination-market device/IVD classification and authorization/conformity evidence for the exact model; generic FDA/WHO references are not evidence for the Luang record.
- Model-specific quality/performance verification and current packaging/label artwork before any public certification, accuracy, sterility or compatibility claim.
- Manufacturing/supply-status evidence before any claim that the device is produced, stocked, registered or available through Luang Pharma.
For LP-209, identify the destination country, intended professional use, proposed presentation and the role of your organisation. The appropriate supply route and available documentation must be confirmed for that case.
- Confirm the legal entity, manufacturing site and authorised scope for the proposed supply chain.
- Confirm device classification, intended use, conformity evidence and local import requirements.
- Request relevant product information, specifications and supporting evidence through the company contact.
- Confirm storage, transport, traceability, complaints and safety-reporting responsibilities before any agreement.
The public catalogue extends beyond the initial planned facility modules. A listing does not mean that the dosage form is installed, qualified or licensed at Boten.
04 · External sources
Sources and further reading
External sources are provided for reference. Their authors do not endorse Luang Pharma, and another product’s authorisation does not transfer to this portfolio record. Source availability and wording can change.
Professional enquiries
Request product-specific evidence for LP-209.
State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.