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) (8) Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (7) Blood, Occult, Colorimetric, In Urine (JIO) (6) Dye-Indicator, Ph (Urinary, Non-Quantitative) (CEN) (6) Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (JMT) (4) Test, Urine Leukocyte (LJX) (4) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (4) Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (CDM) (3) Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (JJB) (3) Refractometer For Clinical Use (JRE) (3) Antigens, Nontreponemal, All (GMQ) (2) Dye-Indicator, Ph (Urinary, Non-Quant.) (CEN) (1) Automated Urinalysis System (KQO) (1) Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) (JMA) (1)

Premarket Exempt

No Yes

Clear

TECO DIAGNOSTICS - 10673486000603 Catalog Number : URS-3-50

Device Description : URS-3-50 FINISHED KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : CEN, JIL, JIR

Prescription Use : No

Device Count : 1

TECO DIAGNOSTICS - 10673486000610 Catalog Number : URS-6-100

Device Description : URS-6-100 TECO FINISHED KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : JIL, JIO, CEN, JIR, JMT, LJX

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000627 Catalog Number : URS-4B-100

Device Description : URS-4B-100 TECO DIAGNOSTICS FINISHED KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : JIO, CEN, JIR, JIL

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000634 Catalog Number : URS-4B-100-108

Device Description : URS-4B-100-108 TECO DIAGNOSTICS FINISHED KIT

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : JIO, CEN, JIR, JIL

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000641 Catalog Number : URS-2K-100GL

Device Description : TECO DIAGNOSTICS URS-2K-100GL BOTTLE WITH LABEL

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

Product Code : JIN, JIL

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000658 Catalog Number : URS-10-100W

Device Description : URS-10-100 Finished Kit / Gray Bottle

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000665 Catalog Number : URS-10-100T

Device Description : URS-10 100 Finished Kit for TC-Thunderbolt

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000672 Catalog Number : URS-11-100G

Device Description : URS-11 100 Strips Generic Finished Kit

Device Class : 1

Duns Number: 185067774

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000689 Catalog Number : RPR-100

Device Description : RPR, 1x100 Tests

Device Class : 2

Duns Number: 185067774

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 1

TECO DIAGNOSTICS - 10673486000696 Catalog Number : RPR-500

Device Description : RPR, 1x500 Tests

Device Class : 2

Duns Number: 185067774

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 1

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