KHW

Product Code: KHW

Products Classified as KHW

3383

Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

Entamoeba Histolytica Serological Reagents.

Total Product Life Cycle (TPLC) Devices

3383

Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

Entamoeba Histolytica Serological Reagents.

FDA Consensus Standards

• Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. [30229]: 21 CFR §866.3220 🔎

Pre-market Notifications for KHW

K170728	E. HISTOLYTICA QUIK CHEK	TECHLAB, Inc.
K994101	E. HISTOLYTICA II	TECHLAB, INC.
K955895	E. HISTOLYTICA TEST	TECHLAB, INC.
K954996	TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM	TREND SCIENTIFIC, INC.
K944791	ENTAMOEBA TEST	TECHLAB, INC.
K900604	DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA	BIOVIR LABORATORIES, INC.
K890774	GIARDEIA(TM)	ANTIBODIES INC.
K890003	GIARDIA STOOL ANTIGEN TEST KIT	LMD LABORATORIES
K874849	PROSPECT/GIARDIA	ALEXON BIOMEDICAL, INC.
K870318	AMEBIASIS ELISA TEST KIT	LMD LABORATORIES
K863811	AMEBIASIS MICROASSAY	DIAMEDIX CORP.
K862473	PDQ AMEBIASIS	DIAMEDIX CORP.
K854230	MEBIASIS AGAR GEL DIFFUSION KIT	LMD LABORATORIES
K854017	ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)	LMD LABORATORIES
K853448	HILLCREST AMEBIASIS IHA TEST	HILLCREST BIOLOGICALS

Global Unique Device Identification Database

• 00857031002349: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
• 00857031002202: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
• 00857031002011: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
• 00840239034748: ANTIGEN, ID, HA, CEP, ENTAMOEBA HISTOLYTICA & REL. SPP.
• 00857031002547: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
• 00083059070781: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
• 08305900070781: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
• 07640158219553: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
• 07640158219652: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
• B350GSD0130130: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
• 00840239038302: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
• 04048474034745: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
• 04048474038309: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
• 00894175000282: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.