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TECO DIAGNOSTICS

Last updated September 17, 2026

Information

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

Catalogue (245)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
Teco Diagnostics	URS-3-100 GENERIC LABELED BOTTLE	FDA UDI	Class I	Active
Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test	P596-25	FDA UDI	Class II	Active
Teco Diagnostics Uric Acid Liquid Reagent Set	U582-250	FDA UDI	Class I	Active
Teco Diagnostics Total Lipid Reagent Set	T526-480	FDA UDI	Class I	Active
Teco Diagnostics Cholinesterase Reagent Set	C511-60	FDA UDI	Class I	Active
Teco Diagnostics	URS-10-100 GRAY BOTTLE	FDA UDI	Class I	Active
Teco Diagnostics HDL Cholesterol Reagent Set	H511-30	FDA UDI	Class I	Active
Teco Diagnostics Glucose (Oxidase) Reagent Set	G519-250	FDA UDI	Class II	Active
Teco Diagnostics Triglyceride - GPO Liquid Reagent Set	T532-100	FDA UDI	Class I	Active
Teco Diagnostics	URS-2M-25	FDA UDI	Class II	Active
Teco Diagnostics	URS-1G-100 BOTTLE	FDA UDI	Class II	Active
Teco Diagnostics Uric Acid Liquid Reagent Set	U582-100	FDA UDI	Class I	Active
Teco Diagnostics Uric Acid Reagent Set	U580-240	FDA UDI	Class I	Active
Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set	G520-100	FDA UDI	Class II	Active
Teco Diagnostics	URS-9-100	FDA UDI	Class I	Active
Teco Diagnostics	URS-4S-100 GENERIC	FDA UDI	Class I	Active
Teco Diagnostics Calcium Reagent Set	C503-480	FDA UDI	Class II	Active
Teco Diagnostics	URS-2K-100GL BOTTLE WITH LABEL	FDA UDI	Class I	Active
Teco Diagnostics Magnesium Reagent Kit for TC-Matrix	M527-430TM	FDA UDI	Class I	Active
Teco Diagnostics Direct Bilirubin TC-Matrix	B538-370TM	FDA UDI	Class II	Active
Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-240	U582-1170TC2	FDA UDI	Class I	Active
Teco Diagnostics	URS-10-100 SPANISH	FDA UDI	Class II	Active
Teco Diagnostics	URS-5K-50	FDA UDI	Class I	Active
Teco Diagnostics	URS-6L-100	FDA UDI	Class II	Active
Teco Diagnostics Cholesterol Reagent Set	C509-400	FDA UDI	Class I	Active
Teco Diagnostics	URS-6-100 TECO FINISHED KIT	FDA UDI	Class II	Active
Teco Diagnostics Total Bilirubin TC Matrix	B576-380TM	FDA UDI	Class II	Active
Teco Diagnostics Triglyceride -GPO Reagent Set	T531-150	FDA UDI	Class I	Active
Teco Diagnostics	URS-2M-25 BOTTLE	FDA UDI	Class II	Active
Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix	L533-780TC4	FDA UDI	Class II	Active
Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate)	G571-400	FDA UDI	Class I	Active
Teco Diagnostics Cholesterol TC Matrix	C507-940TM	FDA UDI	Class I	Active
Alkaline Phosphatase (Kinetic Procedure)	A505-240	FDA UDI	Class II	Active
Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix	L533-780TM	FDA UDI	Class II	Active
Teco Diagnostics Triglyceride -GPO Reagent Set	T531-400	FDA UDI	Class I	Active
Teco Diagnostics CSF/Urine Protein Reagent Set	P615-480	FDA UDI	Class II	Active
Alkaline Phosphatase Reagent Set (Colorimetric Endpoint Method)	A506-140	FDA UDI	Class II	Active
Teco Diagnostics Chloride Reagent Set	C501-480	FDA UDI	Class II	Active
Alkaline Phosphatase (Kinetic Procedure)	A505-400	FDA UDI	Class II	Active
Teco Diagnostics Inorganic Phosphorus Reagent Set (UV Method)	I516-480	FDA UDI	Class I	Active
Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set	ASO-100	FDA UDI	Class I	Active
Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-480	U582-1170TC4	FDA UDI	Class I	Active
Alkaline Phosphatase (ALP) Kinetic Method TC Matrix-240/480	A504-780	FDA UDI	Class II	Active
Tc Matrix Clinical Chemistry Analyzer	K073370	FDA 510(k)	Class I	Active
Teco Cx3 Reagent Set For Synchron Cx System	K060120	FDA 510(k)	Class II	Active
Uritek 151 Urine Analyzer, Model Tc-151	K042421	FDA 510(k)	Class I	Active
Carbon Dioxide Reagent Set	K170200	FDA 510(k)	Class II	Active
Tc-Thunderbolt Automated Urine Analyzer System And Tc-Thunderbolt Urs-10 Strips	K141289	FDA 510(k)	Class II	Active
Rheumatoid Factor (rf) Reagenti A Latex Slide Test	K962015	FDA 510(k)	Class II	Active
Uritek Tc-201 Urine Chemistry Test System	K160372	FDA 510(k)	Class II	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.