CEDIA Red Blood Cell Folate Reagent Pack
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K921689 FDA 510(k)
- FDA Product Code
- CGN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1295 FDA 510(k)
- Regulation Number
- 862.1295 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CEDIA Red Blood Cell Folate Reagent Pack is a diagnostic reagent designed for the quantitative determination of folate levels in red blood cells. It employs chemiluminescent enzyme immunoassay technology (CEDIA) to measure folate concentrations, supporting clinical assessments of nutritional deficiencies or hematologic conditions.
This reagent pack is intended for in vitro diagnostic use in clinical chemistry laboratories. Supplied as a single-use kit, it requires no sterilization beyond its original packaging. The device is classified as Class II under FDA regulations (product code CGN) and was granted a Traditional 510(k) clearance in 1992 for substantial equivalence. Storage conditions and lot-specific instructions must be followed as per manufacturer guidelines.
Frequently asked questions
What is the CEDIA Red Blood Cell Folate Reagent Pack used for?
This reagent pack is designed for the quantitative determination of folate levels in red blood cells using chemiluminescent enzyme immunoassay (CEDIA) technology. It supports clinical assessments of folate deficiencies or related hematologic conditions by providing precise measurements of folate concentrations in patient samples.
How is the CEDIA Red Blood Cell Folate Reagent Pack supplied and prepared for use?
The reagent pack is supplied as a single-use kit, meaning each pack is intended for one testing procedure only. No additional sterilization is required beyond the integrity of the original packaging. Follow the manufacturer’s instructions for reconstitution and preparation, as these may vary by lot.
Is the reagent pack sterile, and how should it be stored?
The reagent pack is sterile as supplied within its original packaging. It is not intended for reuse or further sterilization. Storage conditions must adhere to the manufacturer’s guidelines, which typically include protection from light, extreme temperatures, and moisture. Always check the lot-specific instructions for precise storage requirements.
What regulatory pathway was followed for this reagent pack?
The CEDIA Red Blood Cell Folate Reagent Pack was granted a Traditional 510(k) clearance by the FDA in 1992 under substantial equivalence (SESE) for its intended use in clinical chemistry laboratories. It is classified as a Class II device under FDA regulations (product code CGN) and complies with the requirements for in vitro diagnostic devices.
Are there different models or sizes available for this reagent pack?
The CEDIA Red Blood Cell Folate Reagent Pack is supplied as a standardized single-use kit. While the product is designed for consistent performance across lots, variations in reagent composition or packaging may occur between lots. Always verify the lot-specific instructions for any updates or modifications to the testing protocol.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CEDIA 20 20 μg/150 μg Tabletten - Beipackzettel | Apotheken Umschau, K921689 - CEDIA RED BLOOD CELL FOLATE REAGENT PACK | FDA 510(k), CEDIA RED BLOOD CELL FOLATE REAGENT PACK (K921689) — FDA 510 (k ..., CEDIA RED BLOOD CELL FOLATE REAGENT PACK 510(k) K921689 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K921689 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (1)
- FDA 510(k) K921689 24 fields · synced Oct 1, 2026