International Medical Devices Database

Manufacturer Address
Zymed Laboratories Inc., 561 Eccles Ave, South San Francisco CA 94080-1906
Source
USFDA
2 Events
- Recall of Mouse AntiTTF1 2nd Gen Predilute
- Recall of Mouse AntiTTF1 Concentrate

2 devices in the database

Mouse AntiTTF1 2nd Gen Predilute

Model / Serial
Product Number 08-1221, no 510(k) number, Product Code MXZ, lot code 40180205
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
The Firm distributed to a total of 8 domestic consignees and an unspecified number of foreign consignees. The products were distributed to MD, GA, TX, OH, IL, DC, NY and CA. Foreign countries distributed to include France, Portugal, China, Italy, Israel, Philippines, and Germany.
Product Description
Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types of cancer when used to test a patient.

Mouse AntiTTF1 Concentrate

Model / Serial
Product Number 18-0221, no 510(k) number, Product Code MXZ, lot code 40280262.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
The Firm distributed to a total of 8 domestic consignees and an unspecified number of foreign consignees. The products were distributed to MD, GA, TX, OH, IL, DC, NY and CA. Foreign countries distributed to include France, Portugal, China, Italy, Israel, Philippines, and Germany.
Product Description
Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Zymed Laboratories Inc.

2 devices in the database

Mouse AntiTTF1 2nd Gen Predilute

Mouse AntiTTF1 Concentrate