LW SCIENTIFIC, INC.

LW SCIENTIFIC, INC.

Address:865 Marathon Pkwy,LAWRENCEVILLE,GA,30046,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) (4) Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (3) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (3) Blood, Occult, Colorimetric, In Urine (JIO) (3) Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (JQC) (2) Dye-Indicator, Ph (Urinary, Non-Quant.) (CEN) (2) Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (JJB) (1) Test, Urine Leukocyte (LJX) (1) Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (JMT) (1) Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (CDM) (1) Hemocytometer (GHO) (1) Mixer, Blood Tube (GLE) (1) Refractometer For Clinical Use (JRE) (1)

Premarket Exempt

No Yes

Clear

Urine Reagent Strips, 1-parameter, ketone - 00664816000014 Catalog Number :

Device Description : Urine reagent strips; 1-parameter; ketone; 100 strips per vial

Device Class : 1

Duns Number: 785335381

Premarket Exempt : No

Product Code : JIN

Prescription Use : No

Device Count : 1

Urine Reagent Strips, 10-parameter - 00664816000021 Catalog Number :

Device Description : Urine reagent strips; 10-parameter; 100 strips per vial

Device Class : 1

Duns Number: 785335381

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Urine Reagent Strips, 5-parameter - 00664816000045 Catalog Number :

Device Description : Urine reagent strips; 5-parameter; 100 strips per vial

Device Class : 1

Duns Number: 785335381

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Urine Reagent Strips, 2-parameter; glucose, protein - 00664816000052 Catalog Number :

Device Description : Urine reagent strips; 2-parameter; glucose, protein; 100 strips per vial

Device Class : 1

Duns Number: 785335381

Premarket Exempt : No

Product Code : JIL, JIR

Prescription Use : No

Device Count : 1

Urine Reagent Strips, 1-parameter, glucose - 00664816000069 Catalog Number :

Device Description : Urine reagent strips; 1-parameter; glucose; 100 strips per vial

Device Class : 2

Duns Number: 785335381

Premarket Exempt : No

Product Code : JIL

Prescription Use : No

Device Count : 1

Urine Reagent Strips, 1-parameter, blood - 00664816000076 Catalog Number :

Device Description : Urine reagent strips; 1-parameter; blood; 100 strips per vial

Device Class : 2

Duns Number: 785335381

Premarket Exempt : No

Product Code : JIO

Prescription Use : No

Device Count : 1

LW Scientific, Inc. - 00664816000151 Catalog Number : MXL-BLF7-16T1

Device Description : Blood Rocker, Mixer; 16 tubes, 110V

Device Class : 1

Duns Number: 785335381

Premarket Exempt : Yes

Product Code : GLE

Prescription Use : No

Device Count : 1

LW Scientific, Inc - 00664816000199 Catalog Number : E8C-U8AF-1503

Device Description : Centrifuge; E8 Fixed Speed; 8-place test tube

Device Class : 1

Duns Number: 785335381

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : No

Device Count : 1

LW Scientific, Inc. - 00664816000212 Catalog Number : CTL-HEMM-GLDR

Device Description : Hemacytometer, with cover glass

Device Class : 1

Duns Number: 785335381

Premarket Exempt : Yes

Product Code : GHO

Prescription Use : No

Device Count : 1

LW Scientific, Inc - 00664816000717 Catalog Number : E8C-U8AD-15T3

Device Description : USA E8 Digital Speed Centrifuge

Device Class : 1

Duns Number: 785335381

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : No

Device Count : 1

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