Raichem Spia Haptoglobin Reagent
by Reagents Applications, Inc. 510(k)
Active
510(k) K911898
Overview
The Raichem Spia Haptoglobin Reagent is an immunological test system used to measure haptoglobin in serum. Haptoglobin is a protein that binds hemoglobin, the oxygen-carrying pigment found in red blood cells, and this device utilizes immunochemical techniques for its detection.
This device is classified as a Class 2 medical device under regulation number 866.5460. It has received FDA 510(k) clearance as a substantially equivalent product.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911898 | Date8 May 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Raichem(Tm) Spia(Tm) Haptoglobin Reagent
- 510(k) Number
- FDA Product Code
- DAD
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5460
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Reagents Applications, Inc.
Questions
What is the primary function of the Raichem Spia Haptoglobin Reagent?
This device is an immunological test system used to measure haptoglobin in serum. Haptoglobin is a specific protein that binds to hemoglobin, the oxygen-carrying pigment found in red blood cells, and this reagent uses immunochemical techniques to detect it.
What is the regulatory status of this reagent?
The Raichem Spia Haptoglobin Reagent is classified as a Class 2 medical device under regulation number 866.5460. It has received FDA 510(k) clearance as a substantially equivalent product under K-number K911898.
Which medical specialty oversees this device?
This device falls under the Immunology medical specialty. It is categorized by the Immunology advisory committee, which reviews test systems designed for the detection of specific proteins and antigens in clinical samples.