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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 3 of 5

Device	Model / Reference	Registries	Class	Status
Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set	C512-60	FDA UDI	Class II	Active
Teco Diagnostics	URS-3-50-01 MUSTAFA	FDA UDI	Class I	Active
Alkaline Phosphatase Liquid Reagent (Kinetic Procedure)	A504-150	FDA UDI	Class II	Active
Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit	URS-PBG-1	FDA UDI	Class I	Active
Teco Diagnostics	URS-3-100	FDA UDI	Class I	Active
Teco Diagnostics g-Glutamyl Transferase (GGT) Liquid Reagent Set (Kinetic)	G572-150	FDA UDI	Class I	Active
Teco Diagnostics	URS-2M-25 GENERIC	FDA UDI	Class II	Active
Teco Diagnostics Urine Reagent Strips (URS-1G)	URS-1G-25	FDA UDI	Class II	Active
Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix	L533-780TC2	FDA UDI	Class II	Active
Teco Diagnostics Iron/TIBC Reagent Set	I592-100	FDA UDI	Class I	Active
Teco Diagnostics	URS-3-100 GENERIC	FDA UDI	Class I	Active
Teco Diagnostics	URS-10-100 USA	FDA UDI	Class II	Active
Teco Diagnostics Creatinine (Kinetic or Manual Endpoint Method) Reagent Set	C513-480	FDA UDI	Class II	Active
Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set	G520-480	FDA UDI	Class II	Active
Teco Diagnostics	URS-2L-POUCH-G	FDA UDI	Class I	Active
Teco Diagnostics	URS-3-50 FINISHED KIT	FDA UDI	Class I	Active
Teco Diagnostics	URS-4B-100	FDA UDI	Class II	Active
Teco Diagnostics Chloride Reagent Set TC Matrix	C501-580TM	FDA UDI	Class II	Active
Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix	H513-330TM	FDA UDI	Class I	Active
Teco Diagnostics Hemoglobin Reagent Set	H526-480	FDA UDI	Class II	Active
Teco Diagnostics Direct Bilirubin Reagent Set	B538-480	FDA UDI	Class II	Active
Teco Diagnostics Cholesterol Reagent Set	C509-150	FDA UDI	Class I	Active
Albumin Reagent Set	A502-480	FDA UDI	Class II	Active
Teco Diagnostics	URS-1B-100	FDA UDI	Class II	Active
Teco Diagnostics Rheumatoid Factor (RF) Reagent Set	RF-100	FDA UDI	Class II	Active
Teco Diagnostics Creatinine (Kinetic) Reagent Set	C514-480	FDA UDI	Class II	Active
Teco Diagnostics	RPR-500	FDA UDI	Class II	Active
Teco Diagnostics TC Matrix Clinical Chemistry Analyzer	TC-Matrix	FDA UDI	Class II	Active
Α – Amylase Liquid Reagent (kinetic Method) Tc Matrix-240/480	A532-200	FDA UDI	Class II	Active
Teco Diagnostics	URS-2P-100 BOTTLE	FDA UDI	Class II	Active
Teco Diagnostics TC Matrix Clinical Chemistry Analyzer	TC-Matrix-240	FDA UDI	Class II	Active
Teco Diagnostics Magnesium Reagent Set	M527-100	FDA UDI	Class I	Active
Teco Diagnostics	URS-2P-100 GENERIC	FDA UDI	Class II	Active
Teco Diagnostics Glucose (Hexokinase) Liquid Reagent	G516-150	FDA UDI	Class II	Active
Teco Diagnostics	URS-10-100	FDA UDI	Class II	Active
Teco Diagnostics	URS-1K-100	FDA UDI	Class I	Active
Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method)	B551-132	FDA UDI	Class II	Active
Teco Diagnostics g-Glutamyl Transferase (GGT) Liquid Reagent Kit TC-Matrix-240	G572-780TC2	FDA UDI	Class I	Active
Alt (sgpt) Liquid Reagent (kinetic Method)	A524-150	FDA UDI	Class I	Active
Alt (sgpt) Reagent Set (uv-Kinetic Method)	A525-400	FDA UDI	Class I	Active
Teco Diagnostics	URS-2K-100 BOTTLE	FDA UDI	Class II	Active
Teco Diagnostics Urea Nitrogen (BUN) Liquid Reagent Set	B549-150	FDA UDI	Class II	Active
Teco Diagnostics	URS-1K-100 BOTTLE	FDA UDI	Class I	Active
Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test	P596-A	FDA UDI	Class II	Active
Teco Diagnostics	URS-5K-100 BOTTLE	FDA UDI	Class I	Active
Teco Diagnostics Urea Nitrogen (BUN) Reagent Set	B550-400	FDA UDI	Class II	Active
Teco Diagnostics Cholesterol (Liquid) Reagent Set	C507-480	FDA UDI	Class I	Active
Teco Diagnostics	URS-2P-100	FDA UDI	Class II	Active
Teco Diagnostics	URS-10-100 GENERIC	FDA UDI	Class II	Active
Acid Phosphatase Reagent Set (kinetic Method)	A591-60	FDA UDI	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.