Manufacturer

Techlab

United StatesLegal entities : TECHLAB, Inc.

Markets : Netherlands · United States

Approvals : EU – class B · United States (FDA) – 510(k) : 36 · class I, II · latest in 2019 · see on the FDA website

EU representative : Emergo Europe B.V. (Netherlands)

11 categories, 20 models including 20 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
C.difficile toxin a/b detection	W0105011802	C. DIFFICILE TOX A/B II2 refs98/79 C. DIFFICILE TOX-B TEST98/79 TOX A/B QUIK CHEK98/79	– 98/79	EUDAMED record Report an error
Parasitology - other	W0105050299	GIARDIA/CRYPTOSPORIDIUM CHEK98/79 GIARDIA/CRYPTOSPORIDIUM QUIK CHEK TRI-COMBO PARASITE SCREEN98/79	B IVDR, 98/79	EUDAMED record Report an error
C.difficile GDH detection	W0105011801	C. DIFF CHEK -602 refs98/79 C. DIFF QUIK CHEK98/79	– 98/79	EUDAMED record Report an error
Campylobacter direct antigen detection	W0105011401	CAMPYLOBACTER CHEK98/79 CAMPYLOBACTER QUIK CHEK98/79	– 98/79	EUDAMED record Report an error
E. coli toxin	W0105011502	SHIGA TOXIN CHEK98/79 SHIGA TOXIN QUIK CHEK	B IVDR, 98/79	EUDAMED record Report an error
Entamoeba histolytica	W0105050201	E. HISTOLYTICA II T501798/79 E. HISTOLYTICA QUIK CHEK98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	H. PYLORI CHEK98/79 H. PYLORI QUIK CHEK98/79	– 98/79	EUDAMED record Report an error
Bacteriology immunoassay - other	W0105011799	Clostridium Perfringens Enterotoxin Test98/79	– 98/79	EUDAMED record Report an error
C.difficile GDH and toxin a/b combined detection	W0105011803	C. DIFF QUIK CHEK COMPLETE2 refs	B IVDR	EUDAMED record Report an error
Cryptosporidium	W0105050207	CRYPTOSPORIDIUM II98/79	– 98/79	EUDAMED record Report an error
Giardia lamblia	W0105050208	GIARDIA II PT501298/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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