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Sign in to claim this brandAMERICAN NATIONAL RED CROSS
US
Last updated May 24, 2026
What AMERICAN NATIONAL RED CROSS makes
American National Red Cross manufactures in vitro diagnostic reagents for red blood cell grouping, including various antibodies such as Anti-Fy^a, Anti-K, Anti-Kp^a, Anti-Kp^b, Anti-M, and Anti-S. Their product portfolio also includes red cell storage solutions, PEG, LISS, control cells, and the DailyChek QC Kit.
These devices are classified as Class I and Class II medical devices and are listed in the FDA UDI database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does American National Red Cross manufacture?
American National Red Cross specializes in in vitro diagnostic (IVD) reagents used for red blood cell grouping. These include specific antibodies like Anti-Fy^a, Anti-K, Anti-Kp^a, Anti-Kp^b, Anti-M, and Anti-S, which help identify blood type compatibility. Their portfolio also covers supporting products such as red cell storage solutions, PEG (polyethylene glycol), LISS (Low Ionic Strength Solution), control cells, and quality control kits like the DailyChek QC Kit. These devices are designed for laboratory use in blood banking and transfusion medicine.
Where is American National Red Cross based, and what does that mean for its regulatory oversight?
American National Red Cross is based in the United States. Since the company operates within the U.S., its devices are subject to regulatory oversight by the FDA (U.S. Food and Drug Administration). The FDA’s UDI (Unique Device Identifier) database lists their products, which helps track and manage these devices for compliance and transparency in the healthcare system.
How are the devices manufactured by American National Red Cross classified under medical device regulations?
The devices produced by American National Red Cross fall into two regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and often require general controls for safety and effectiveness, while Class II devices involve a higher level of risk and may require special controls to ensure their performance. The classification determines the regulatory pathway and scrutiny each device undergoes before entering the market.
Which regulatory registries or databases list the devices made by American National Red Cross?
The devices manufactured by American National Red Cross are listed in the FDA’s UDI (Unique Device Identifier) database. This registry assigns a unique identifier to each device, enabling better tracking, traceability, and compliance monitoring in the healthcare system. Listing in this database is a requirement for medical devices marketed in the U.S.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 003255213
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Red Cell Storage Solution | 510265 | FDA UDI | Class I | Active |
| Anti-k | 510202 | FDA UDI | N/A | Active |
| Peg | 510179 | FDA UDI | Class II | Active |
| Anti-Fya | 510215 | FDA UDI | N/A | Active |
| Anti-Kpa | 510204 | FDA UDI | N/A | Active |
| Anti-S | 510222 | FDA UDI | N/A | Active |
| Liss | 510177 | FDA UDI | Class II | Active |
| DailyChek QC Kit | 510395 | FDA UDI | Class II | Active |
| Anti-M | 510206 | FDA UDI | N/A | Active |
| Anti-s | 510224 | FDA UDI | N/A | Active |
| Control Cells | 510400/510402 | FDA UDI | Class II | Active |
| Anti-K | 510200 | FDA UDI | N/A | Active |
| Anti-Kpb | 510205 | FDA UDI | N/A | Active |
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