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TECO DIAGNOSTICS

Last updated September 17, 2026

Information

Country: US
Address: 1268 NORTH LAKEVIEW AVE., ANAHEIM, CA, 92807
Website: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1832216
DUNS Number: —

Catalogue (245)

Page 1 of 5

Device	Model / Reference	Registries	Class	Status
Teco Diagnostics Glucose (Hexokinase) Reagent Set	G518-400	FDA UDI	Class II	Active
Teco Diagnostics	URS-10-100 LABELED BOTTLE	FDA UDI	Class II	Active
Teco Diagnostics TC Matrix Clinical Chemistry Analyzer	TC-MATRIX-160	FDA UDI	Class II	Active
Teco Diagnostics Triglyceride - GPO Liquid Reagent Set	T532-200	FDA UDI	Class I	Active
Teco Diagnostics Direct LDL Cholesterol Reagent Set	L530-100	FDA UDI	Class I	Active
Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set	C614-30	FDA UDI	Class II	Active
Teco Diagnostics	URS-OBGYN-100	FDA UDI	Class II	Active
Teco Diagnostics	URS-1K-50	FDA UDI	Class I	Active
GLUCOPAD TC-SMART+ Lancets Kit	G852-E-001	FDA UDI	Class II	Unknown
Teco Diagnostics Glucopad Blood Glucose Test Strips	Glucopad Blood Glucose Test Strips	FDA UDI	Class II	Active
Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System	TC-Thunderbolt	FDA UDI	Class I	Active
Teco Diagnostics Glucose (Oxidase) Reagent Set	G519-1L	FDA UDI	Class II	Active
Teco Diagnostics	URS-5K-100	FDA UDI	Class I	Active
Teco Diagnostics Glucose (Hexokinase) Reagent Set	G518-150	FDA UDI	Class II	Active
Teco Diagnostics	URS-1G-100	FDA UDI	Class II	Active
Teco Diagnostics	URS-4S-100	FDA UDI	Class I	Active
Teco Diagnostics Uric Acid Reagent Set	U580-400	FDA UDI	Class I	Active
Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent Set	G560-125	FDA UDI	Class II	Active
Teco Diagnostics Total Protein Reagent Set	T528-480	FDA UDI	Class II	Active
Teco Diagnostics Lactate Dehydrogenase (LDH-L) Liquid Reagent Set	L533-150	FDA UDI	Class II	Active
Amylase Reagent Set (kinetic Method)	A533-60	FDA UDI	Class II	Active
Teco Diagnostics	URS-1B-50-01 MUSTAFA	FDA UDI	Class II	Active
Teco Diagnostics Cholesterol (Liquid) Reagent Set	C507-100	FDA UDI	Class I	Active
Teco Diagnostics Total Bilirubin Reagent Set	B576-480	FDA UDI	Class II	Active
Teco Diagnostics	URS-3-100 BOTTLE	FDA UDI	Class I	Active
Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set for TC Matrix	G520-940TM	FDA UDI	Class II	Active
Teco Diagnostics	URS-9-100 BOTTLE	FDA UDI	Class I	Active
Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set	G520-1L	FDA UDI	Class II	Active
Teco Diagnostics Direct and Total Bilirubin Reagent Set	B577-480	FDA UDI	Class II	Active
Teco Diagnostics One-Step Pregnancy Dipstick Test	P595-100	FDA UDI	Class II	Active
Alt (sgpt) Kinetic Method Tc Matrix-240/480	A524-780	FDA UDI	Class I	Active
Teco Diagnostics LDH-L Reagent Set	L535-60	FDA UDI	Class II	Active
Ast (sgot) Reagent Set (uv-Kinetic Method)	A560-240	FDA UDI	Class II	Active
Teco Diagnostics	URS-4B-100-108	FDA UDI	Class II	Active
Α – Amylase Liquid Reagent (kinetic Method)	A532-150	FDA UDI	Class II	Active
Teco Diagnostics	URS-9-100 GENERIC	FDA UDI	Class I	Active
Teco Diagnostics Triglyceride Reagent Kit TC-Matrix	T532-1170TM	FDA UDI	Class I	Active
Ast (sgot) Reagent Set (uv-Kinetic Method)	A560-400	FDA UDI	Class II	Active
Teco Diagnostics HDL Cholesterol Reagent Set	H511-20	FDA UDI	Class I	Active
Teco Diagnostics Carbon Dioxide (CO2) Reagent Set	C525-60	FDA UDI	Class II	Active
Teco Diagnostics Lipase Reagent Set	L537-100	FDA UDI	Class I	Active
Teco Diagnostics Creatinine Reagent Set (Direct Endpoint Procedure)	C515-480	FDA UDI	Class II	Active
Teco Diagnostics	URS-10 100 Teco (RUSSIAN)	FDA UDI	Class II	Active
Teco Diagnostics	URS-2K-100	FDA UDI	Class II	Active
Teco Diagnostics Triglyceride - GPO Liquid Reagent Set	T532-480	FDA UDI	Class I	Active
Teco Diagnostics Creatine Kinase (CK-NAC) Liquid Reagent	C519-150	FDA UDI	Class II	Active
Teco Diagnostics	URS-4S-100 BOTTLE	FDA UDI	Class I	Active
Teco Diagnostics Uritek TC-201 Urine Chemistry Test System	TC-201	FDA UDI	Class I	Active
Albumin -BCG method TC-Matrix	A502-510TM	FDA UDI	Class II	Active
Teco Diagnostics Iron Reagent Kit for TC Matrix	I592-380TM	FDA UDI	Class I	Active

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FDA Recalls (10)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 14, 2011	Z-0512-2012	—	terminated	This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has been initiated due to improper manufacture of sub-component nitrite paper Lot 35134, Expiration Date: 01/2014. Discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets. Sampling size submitted for QC testing was insufficient based upon number o
Oct 14, 2011	Z-0511-2012	—	terminated	This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has been initiated due to improper manufacture of sub-component nitrite paper Lot 35134, Expiration Date: 01/2014. Discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets (Refer to next paragraph). Sampling size submitted for QC testing was insuff
Oct 1, 2010	Z-0578-2011	—	terminated	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
Oct 1, 2010	Z-0579-2011	—	terminated	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
Oct 1, 2010	Z-0577-2011	—	terminated	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
Oct 1, 2010	Z-0582-2011	—	terminated	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
Oct 1, 2010	Z-0581-2011	—	terminated	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
Oct 1, 2010	Z-0580-2011	—	terminated	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
Oct 1, 2010	Z-0583-2011	—	terminated	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
Dec 22, 2005	Z-0472-06	—	terminated	When reading the Nitrite parameter on the Teco Diagnostics URS-10 strips, some positive nitrite samples may be read by the machine as negative.