Bcg Albumin Reaget
by Analytical & Research Chemicals, Inc. 510(k)
Active
510(k) K781441
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781441 | Date10 Oct 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CIX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1035
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The BCG Albumin Reagent is a diagnostic reagent used for the quantitative determination of albumin in biological samples. Classified under the nomenclature ‘Bromcresol Green Dye-Binding, Albumin,’ it employs the bromocresol green dye-binding principle to measure albumin concentration, a key indicator in clinical chemistry assessments.
This reagent is supplied as a traditional Class II device, cleared under FDA 510(k) (K781441) and regulated under 21 CFR 862.1035. It is intended for in vitro use in clinical chemistry laboratories, requiring no special handling beyond standard reagent preparation. The product is not sterile, single-use, or MRI-compatible, and no specific storage conditions are noted beyond typical reagent storage. Authorisations include FDA clearance and registration under multiple FEI numbers.
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Questions
AI-generated answers, 1 Oct 2026
What is the BCG Albumin Reagent used for?
The BCG Albumin Reagent is designed for the quantitative determination of albumin in biological samples. Albumin is a critical protein in clinical chemistry, often used to assess liver function, nutritional status, and overall health. This reagent employs the bromocresol green dye-binding principle to accurately measure albumin concentration, making it a reliable tool for laboratories performing such tests.
How is the BCG Albumin Reagent supplied and prepared?
The BCG Albumin Reagent is supplied as a traditional Class II diagnostic reagent. It requires standard reagent preparation procedures in clinical chemistry laboratories. No special handling beyond typical reagent preparation is necessary, as it is not sterile, single-use, or intended for direct patient administration. Always follow manufacturer guidelines for accurate dilution and use.
Is the BCG Albumin Reagent sterile or intended for single-use?
No, the BCG Albumin Reagent is not sterile and is not designed for single-use. It is intended for in vitro diagnostic use in laboratory settings, where multiple tests can be performed from a single reagent bottle. Proper aseptic technique should be followed when handling the reagent to prevent contamination, but the reagent itself is not sterile.
What regulatory approvals does the BCG Albumin Reagent hold?
The BCG Albumin Reagent is cleared by the FDA under a 510(k) pathway (K781441) and is regulated under 21 CFR 862.1035. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness. The reagent is also registered under multiple FEI numbers, reflecting its compliance with FDA registration requirements.
Are there any special storage requirements for the BCG Albumin Reagent?
The BCG Albumin Reagent does not specify any special storage conditions beyond typical reagent storage. It should be stored in a clean, dry environment, protected from extreme temperatures and direct light. Always check the manufacturer’s instructions for any additional recommendations, such as refrigeration or expiration details, to ensure optimal performance and accuracy of results.