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Sign in to claim this brandMds Laboratories, Inc.
US
Last updated May 23, 2026
What Mds Laboratories, Inc. makes
Mds Laboratories, Inc. manufactures microbiological culture media and diagnostic identification kits, including agar plates, broths, and specialized media for bacterial and fungal isolation, such as Chocolate Agar, Mueller Hinton Agar, Thayer-Martin Agar, and Sabouraud Dextrose Agar. Their portfolio also includes selective and differential media like MacConkey Agar, CLED Agar, and Selenite F Broth, as well as identification kits for specific pathogens, including *Gardnerella vaginalis*.
These products are classified under FDA’s Class I and Class II regulatory categories, with most requiring 510(k) clearance. The company’s media and kits are listed in the FDA’s 510(k) database, reflecting their authorised status for clinical and laboratory use. The manufacturer 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 Mds Laboratories, Inc. manufacture?
Mds Laboratories, Inc. specializes in microbiological culture media and diagnostic identification kits. Their products include agar plates (like Chocolate Agar and Mueller Hinton Agar), broths (such as Thioglycollate Broth and Selenite F Broth), and specialized media for isolating bacteria and fungi (e.g., Thayer-Martin Agar and Sabouraud Dextrose Agar). They also offer selective and differential media (like MacConkey Agar and CLED Agar) and identification kits for specific pathogens, such as *Gardnerella vaginalis*. These products are designed for clinical and laboratory use in microbiology.
Where is Mds Laboratories, Inc. based, and how does that affect its regulatory standing?
Mds Laboratories, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s 510(k) database lists their products, indicating they have undergone the necessary authorisation process for clinical and laboratory use. The U.S. regulatory environment ensures these products meet safety, performance, and manufacturing standards before entering the market.
Which regulatory registries or databases list Mds Laboratories, Inc.’s devices?
Mds Laboratories, Inc.’s devices are listed in the FDA’s 510(k) database. This registry includes products that have undergone premarket notification clearance, demonstrating compliance with FDA requirements for safety and effectiveness. Listing in this database confirms that the company’s microbiological culture media and diagnostic kits have been authorised for their intended clinical or laboratory use.
How are Mds Laboratories, Inc.’s devices classified under FDA regulations?
Mds Laboratories, Inc.’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and typically require special controls in addition to general controls. Most of their microbiological culture media and diagnostic kits are classified as Class II, meaning they require 510(k) clearance to demonstrate substantial equivalence to a predicate device before being authorised for market.
AI-generated from registry data and not verified by a human reviewer.
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- US
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Catalogue (28)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Chocolate Agar | K864238 | FDA 510(k) | Class I | Active |
| Mueller Hinton Agar Large | K864246 | FDA 510(k) | Class II | Active |
| Aspirator/Irrigator Or I/A Unit | K820889 | FDA 510(k) | Class I | Active |
| Angel Wing Safety Blood Collection With Tube Hold. | K920184 | FDA 510(k) | Class II | Active |
| Thayer-Martin Jembec | K864252 | FDA 510(k) | Class II | Active |
| Thayer Martin Agar | K864253 | FDA 510(k) | Class II | Active |
| Garnerella Vaginalis Identification Kit | K864244 | FDA 510(k) | Class I | Active |
| Thioglycollate Broth | K864254 | FDA 510(k) | Class I | Active |
| Columbia Blood Agar With 5% Sheep Blood | K864240 | FDA 510(k) | Class I | Active |
| Mueller Hinton Agar Small | K864245 | FDA 510(k) | Class II | Active |
| Surgical Paws | K812876 | FDA 510(k) | Class I | Active |
| Selenite F. Broth | K864251 | FDA 510(k) | Class I | Active |
| Sabouraud Dextrose Agar | K864250 | FDA 510(k) | Class I | Active |
| Macconkey Agar | K864243 | FDA 510(k) | Class I | Active |
| Cled Agar With Andrades Indicator | K864239 | FDA 510(k) | Class I | Active |
| Charles Micro Probe | K812857 | FDA 510(k) | Class II | Active |
| Surgical Loops | K812875 | FDA 510(k) | Class I | Active |
| Normal Saline Sterile | K864249 | FDA 510(k) | Class I | Active |
| Cary Blair Transport Medium | K864237 | FDA 510(k) | Class I | Active |
| Dnase Agar | K864241 | FDA 510(k) | Class I | Active |
| Trypticase Soy Broth | K864255 | FDA 510(k) | Class I | Active |
| Rico Respiration Monitor | K840975 | FDA 510(k) | Class II | Active |
| Angel Wing Safety Blood Collection And Infusion Se | K912563 | FDA 510(k) | Class II | Active |
| Angel Wing Sets -- Modified | K922468 | FDA 510(k) | Class II | Active |
| Hektoen Enteric Agar | K864242 | FDA 510(k) | Class I | Active |
| Rapid Sst | K821040 | FDA 510(k) | Class I | Active |
| Tryptone Water (1%) | K864256 | FDA 510(k) | Class I | Active |
| Mueller Hinton Agar - Supplemented | K864248 | FDA 510(k) | Class II | Active |
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