TECO DIAGNOSTICS

Address:1268 NORTH LAKEVIEW AVE.,ANAHEIM,CA,92807,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (JIL) (9) Dye-Indicator, Ph (Urinary, Non-Quant.) (CEN) (9) Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (9) Blood, Occult, Colorimetric, In Urine (JIO) (7) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (7) Refractometer For Clinical Use (JRE) (6) Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (JMT) (5) Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (JJB) (4) Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (CDM) (4) Test, Urine Leukocyte (LJX) (2)

Premarket Exempt

No Yes

Clear

TECO DIAGNOSTICS - 10673486000337 Catalog Number : URS-4S-100B

Device Description : URS-4S-100 BOTTLE

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : JRE, CEN, JIR, JIL

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000344 Catalog Number : URS-4S-100G

Device Description : URS-4S-100 GENERIC FINISHED KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : JRE, CEN, JIR, JIL

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000351 Catalog Number : URS-5K-100

Device Description : URS-5K-100 FINISHED KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : JIR, JIL, JIO, CEN, JIN

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000368 Catalog Number : URS-5K-100B

Device Description : URS-5K-100 BOTTLE

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : CEN, JIO, JIN, JIR, JIL

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000375 Catalog Number : URS-5K-100G

Device Description : URS-5K-100 GENERIC FINISHED KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : JIR, JIL, JIO, CEN, JIN

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000382 Catalog Number : URS-9-100

Device Description : URS-9-100 FINISHED KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : JMT, CDM, JIR, CEN, JIO, JRE, JIN, JJB, JIL

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000399 Catalog Number : URS-9-100B

Device Description : URS-9-100 BOTTLE ONLY

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : JMT, CDM, JIR, CEN, JIO, JRE, JIN, JJB, JIL

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000405 Catalog Number : URS-9-100G

Device Description : URS-9-100 GENERIC FINISHED KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : JMT, CDM, JIR, CEN, JIO, JRE, JIN, JJB, JIL

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000412 Catalog Number : URS-2L-POUCH-G

Device Description : URS 2L POUCH (UTI POUCH)

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : LJX, JMT

Prescription Use : No

Device Count : 1

TECO DIAGNOSTICS - 10673486000429 Catalog Number : URS-11-100

Device Description : URS-11-100 FINISHED KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : LJX, JMT, CDM, JIR, CEN, JIO, JRE, JIN, JJB, JIL

Prescription Use : Yes

Device Count : 1

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