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US
Last updated May 24, 2026
What MICRO TYPING SYSTEMS, INC makes
Micro Typing Systems, Inc. manufactures manual laboratory liquid dispensers and in vitro diagnostic (IVD) kits for blood typing. Their products include agglutination-based ABO/Rh blood grouping kits, buffered sample diluents, and gel column agglutination centrifuges. Specific IVDs cover red blood cell antibody testing for antigens such as Anti-A, Anti-B, Anti-C (RH002), and Anti-C (RH004).
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in clinical and laboratory settings, adhering to regulatory requirements for in vitro diagnostics and general laboratory equipment 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 Micro Typing Systems, Inc. manufacture?
Micro Typing Systems, Inc. specializes in manual laboratory liquid dispensers and in vitro diagnostic (IVD) kits designed for blood typing. Their products include ABO/Rh blood grouping kits that use agglutination methods, buffered sample diluents for preparing blood samples, and gel column agglutination centrifuges. Additionally, they offer specific IVD antibodies for red blood cell grouping, such as Anti-A, Anti-B, Anti-C (RH002), and Anti-C (RH004). These devices are primarily used in clinical and laboratory settings to ensure accurate blood typing and compatibility testing.
Where is Micro Typing Systems, Inc. based, and what regulatory databases list their devices?
Micro Typing Systems, Inc. is based in the United States. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which serves as a centralized registry for tracking medical devices authorized for use in the U.S. This database helps healthcare providers, regulators, and manufacturers identify and verify the devices in circulation.
How are the devices manufactured by Micro Typing Systems, Inc. classified under FDA regulations?
The devices produced by Micro Typing Systems, Inc. fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on the specific device type, with in vitro diagnostics like blood typing kits often falling into Class II due to their role in critical patient care decisions.
What is the primary purpose of the devices manufactured by Micro Typing Systems, Inc.?
The primary purpose of Micro Typing Systems, Inc.’s devices is to facilitate accurate blood typing and compatibility testing in clinical and laboratory environments. Their manual liquid dispensers, agglutination kits, and gel column centrifuges are designed to prepare and analyze blood samples for ABO/Rh grouping and red blood cell antibody detection. These processes are essential for ensuring safe blood transfusions and reducing the risk of adverse reactions in patients.
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
- 781421888
Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mts | MTS9612 | FDA UDI | Class I | Active |
| Mts | MTS084014 | FDA UDI | N/A | Active |
| Mts | MTS081001 | FDA UDI | Class II | Active |
| Mts | MTS080015 | FDA UDI | N/A | Active |
| Mts | MTS080017 | FDA UDI | N/A | Active |
| Mts | MTS081221 | FDA UDI | N/A | Active |
| Mts | MTS9330 | FDA UDI | Class II | Active |
| Mts | MTS080210 | FDA UDI | N/A | Active |
| Mts | MTS080515 | FDA UDI | N/A | Active |
| Mts | MTS9680 | FDA UDI | Class I | Active |
| Mts | MTS085014 | FDA UDI | Class II | Active |
| Mts | MTS9640 | FDA UDI | Class I | Active |
| Mts | MTS9650 | FDA UDI | Class I | Active |
| Mts | MTS084024 | FDA UDI | N/A | Active |
| Mts | MTS080312 | FDA UDI | N/A | Active |
| Mts | MTS080014 | FDA UDI | N/A | Active |
| Mts | MTS080212 | FDA UDI | N/A | Active |
| Mts | MTS081115 | FDA UDI | N/A | Active |
| Mts | MTS080310 | FDA UDI | N/A | Active |
| Mts | MTS9610 | FDA UDI | Class I | Active |
| Mts | MTS9230 | FDA UDI | Class II | Active |
| Mts | MTS080016 | FDA UDI | N/A | Active |
| Mts | MTS080024 | FDA UDI | N/A | Active |
| Mts | MTS5150-60 | FDA UDI | Class II | Active |
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