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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 2 of 5

Device	Model / Reference	Registries	Class	Status
Teco Diagnostics Vaginal pH Screening Kit	MRS-OBGYN-VPH	FDA UDI	Class I	Active
Teco Diagnostics TC Matrix Clinical Chemistry Analyzer	TC-Matrix-480	FDA UDI	Class II	Active
Teco Diagnostics Direct HDL Cholesterol Reagent Set	H513-100	FDA UDI	Class I	Active
Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set	C512-240	FDA UDI	Class II	Active
Teco Diagnostics	URS-11-100 GENERIC	FDA UDI	Class I	Active
Teco Diagnostics Potassium Reagent Set	P605-50	FDA UDI	Class II	Active
Teco Diagnostics Cholesterol TC-Matrix-240	C507-940TC2	FDA UDI	Class I	Active
Teco Diagnostics Creatinine (Kinetic) Reagent Kit TC-MATRIX-240/480	C514-650	FDA UDI	Class II	Active
Teco Diagnostics Hemoglobin A1c Set for TC Matrix Systems	G560-160TM	FDA UDI	Class II	Active
Teco Diagnostics Potassium Reagent TC-Matrix	P605-510TM	FDA UDI	Class II	Active
Teco Diagnostics	URS-1B-100 BOTTLE	FDA UDI	Class II	Active
Teco Diagnostics Cholesterol TC-Matrix-480	C507-940TC4	FDA UDI	Class I	Active
Teco Diagnostics	D770-25	FDA UDI	Class II	Unknown
Alt (sgpt) Reagent Set (uv-Kinetic Method)	A525-240	FDA UDI	Class I	Active
Teco Diagnostics	URS-11-50	FDA UDI	Class I	Active
Teco Diagnostics	URS-2K-100 GENERIC	FDA UDI	Class I	Active
Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate)	G571-150	FDA UDI	Class I	Active
Teco Diagnostics H. pylori Card Test	H730-A	FDA UDI	Class I	Active
Ast/Sgot Liquid Reagent (kinetic Method)	A559-150	FDA UDI	Class II	Active
Teco Diagnostics	URS-1B-100 GENERIC	FDA UDI	Class II	Active
Teco Diagnostics	URS-1G-100 GENERIC LABELED BOTTLE	FDA UDI	Class II	Active
Teco Diagnostics	URS-1K-100 GENERIC	FDA UDI	Class I	Active
Teco Diagnostics BUN (Urea) Reagent Kit TC Matrix-240/480	B549-620	FDA UDI	Class II	Active
Teco Diagnostics	URS-1G-100 GENERIC	FDA UDI	Class II	Active
Teco Diagnostics Total Protein Reagent Kit for TC-Matrix	T528-1300TM	FDA UDI	Class II	Active
Teco Diagnostics Urea Nitrogen (BUN) Reagent Set	B550-240	FDA UDI	Class II	Active
Teco Diagnostics	URS-10-100 TC-THUNDERBOLT	FDA UDI	Class I	Active
Teco Diagnostics Inorganic Phosphorus Reagent Set (Color Method)	I515-480	FDA UDI	Class I	Active
Teco Diagnostics Glucose Hexokinase (Liquid) Reagent Kit for TC-Matrix	G516-870TM	FDA UDI	Class II	Active
Ast (sgot) Kinetic Method Tc Matrix-240/480	A559-780	FDA UDI	Class II	Active
Teco Diagnostics	Glucopad Blood Glucose Monitoring System	FDA UDI	Class II	Active
Teco Diagnostics Creatine Kinase (CK-NAC) Liquid Reagent TC Matrix	C519-440TM	FDA UDI	Class II	Active
Teco Diagnostics	URS-1K-50-01 MUSTAFA	FDA UDI	Class I	Active
Teco Diagnostics Cholesterol Reagent Set	C509-1L	FDA UDI	Class I	Active
Teco Diagnostics Hemoglobin Reagent Set	H526-6L	FDA UDI	Class II	Active
Teco Diagnostics LDH-L Reagent Set	L535-240	FDA UDI	Class II	Active
Teco Diagnostics	URS-5K-100 GENERIC	FDA UDI	Class I	Active
Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method)	B551-66	FDA UDI	Class II	Active
Teco Diagnostics Sodium Reagent Set	S600-50	FDA UDI	Class II	Active
Teco Diagnostics Uric Acid Liquid Reagent Set	U582-480	FDA UDI	Class I	Active
Teco Diagnostics	RPR-100	FDA UDI	Class II	Active
Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System	TC-720+	FDA UDI	Class I	Active
Teco Diagnostics	URS-10-100 BOTTLE	FDA UDI	Class II	Active
Teco Diagnostics Phosphorus Reagent Kit (UV Method) TC Matrix	I516-780TM	FDA UDI	Class I	Active
GLUCOPAD TC-SMART+ Lancets Kit	G852-E-001	FDA UDI	Class II	Active
Teco Diagnostics C-Reactive Protein (CRP) Reagent Set	CRP-100	FDA UDI	Class II	Active
Teco Diagnostics	URS-1P-100	FDA UDI	Class I	Active
Teco Diagnostics g-Glutamyl Transferase (GGT) Liquid Reagent Kit TC-Matrix-480	G572-780TC4	FDA UDI	Class I	Active
Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set	C614-60	FDA UDI	Class II	Active
Teco Diagnostics	URS-11-100	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.