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

Blood, Occult, Colorimetric, In Urine (JIO) (9) Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (8) Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (CDM) (7) Dye-Indicator, Ph (Urinary, Non-Quant.) (CEN) (7) Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (JIL) (7) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (7) Refractometer For Clinical Use (JRE) (7) Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (JJB) (7) Test, Urine Leukocyte (LJX) (7) Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (JMT) (7)

Premarket Exempt

No Yes

Clear

TECO DIAGNOSTICS - 10673486000016 Catalog Number : URS-10-100

Device Description : URS-10-100 FINISHED KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000023 Catalog Number : URS-10 100(R)

Device Description : URS-10 100 (RUSSIAN) FINISHED KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000030 Catalog Number : URS-10-100(S)

Device Description : URS-10-100 SPANISH FINISHED KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000047 Catalog Number : URS-10-100G

Device Description : URS-10-100 GENERIC FINISHED KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000054 Catalog Number : URS-10-100B

Device Description : URS-10-100 BOTTLE ONLY

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000061 Catalog Number : URS-10-100U

Device Description : URS-10-100 USA KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000078 Catalog Number : URS-10-100L

Device Description : URS-10-100 LABELED BOTTLE

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000085 Catalog Number : URS-1B-50-01

Device Description : URS-1B-50-01 FINISHED KIT

Device Class : 2

Duns Number: 185067774

Premarket Exempt : No

Product Code : JIO

Prescription Use : No

Device Count : 1

TECO DIAGNOSTICS - 10673486000092 Catalog Number : URS-1P-100

Device Description : URS-1P 100 Teco Finished Kit

Device Class : 1

Duns Number: 185067774

Premarket Exempt : Yes

Product Code : JIR

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000122 Catalog Number : URS-1B-100

Device Description : URS-1B-100 FINISHED KIT

Device Class : 2

Duns Number: 185067774

Premarket Exempt : No

Product Code : JIO

Prescription Use : Yes

Device Count : 1

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