MERCEDES MEDICAL, LLC

Address:12210 Rangeland Parkway,Lakewood Ranch,FL,34211,US

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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

Enzyme Immunoassay, Opiates (DJG) (4) Enzyme Immunoassay, Amphetamine (DKZ) (4) Enzyme Immunoassay, Barbiturate (DIS) (4) Enzyme Immunoassay, Benzodiazepine (JXM) (4) Thin Layer Chromatography, Morphine (DNK) (4) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (4) Enzyme Immunoassay, Methadone (DJR) (4) Enzyme Immunoassay, Phencyclidine (LCM) (4) Enzyme Immunoassay, Cannabinoids (LDJ) (4) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (3) Thin Layer Chromatography, Methamphetamine (DJC) (3) Reagent, Occult Blood (KHE) (2) Tubes, Vials, Systems, Serum Separators, Blood Collection (JKA) (2) Visual, Pregnancy Hcg, Prescription Use (JHI) (1) Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (JJB) (1) Blood, Occult, Colorimetric, In Urine (JIO) (1) Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (JMT) (1) Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (CDM) (1) Dye-Indicator, Ph (Urinary, Non-Quant.) (CEN) (1) Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (1) Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (JIL) (1) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (1) Test, Urine Leukocyte (LJX) (1) Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) (JMA) (1)

Premarket Exempt

Clear

BluRapids™ - 00850011007105 Catalog Number : TNR CDOA2135

Device Description : BluRapids CLIA Waived Drug Cup; 13 Panel AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MT BluRapids CLIA Waived Drug Cup; 13 Panel AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/THC

Device Class :

Duns Number: 834472680

Premarket Exempt : No

Product Code : LDJ, LFG, LCM, DJR, DNK, DJC, DIO, JXM, DJG, DIS, DKZ

Prescription Use : No

Device Count : 1

BluRapids™ - 00850011007112 Catalog Number : TNR CDOA7125A3

Device Description : BluRapids CLIA Waived Drug Cup; 13 Panel AMP,BAR,BZO,COC,MET,MDMA,OPI300,MTD,OXY BluRapids CLIA Waived Drug Cup; 13 Panel AMP,BAR,BZO,COC,MET,MDMA,OPI300,MTD,OXY,PCP,TCA,THC with 3 AD (+pH, OX,SG)

Device Class :

Duns Number: 834472680

Premarket Exempt : No

Product Code : LDJ, LFG, LCM, DJG, DJR, DNK, DIO, JXM, DIS, DKZ

Prescription Use : No

Device Count : 1

Tanner Scientific® - 00850011007129 Catalog Number : TNR DOA12A

Device Description : Tanner Scientific CLIA waived Drug Cup; 12Panel AMP/BAR/BUP/BZO/COC/MDMA/MET/OPI Tanner Scientific CLIA waived Drug Cup; 12Panel AMP/BAR/BUP/BZO/COC/MDMA/MET/OPI300/MTD/OXY/PCP/THC

Device Class : 2

Duns Number: 834472680

Premarket Exempt : No

Product Code : LDJ, LCM, DJR, DNK, DJC, DIO, JXM, DJG, DIS, DKZ

Prescription Use : No

Device Count : 1

Tanner Scientific® - 00850011007136 Catalog Number : TNR DOA13A

Device Description : Tanner Scientific CLIA waived 13 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/OPI300/MTD/ Tanner Scientific CLIA waived 13 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/OPI300/MTD/OXY/PCP/TCA/THC

Device Class : 2

Duns Number: 834472680

Premarket Exempt : No

Product Code : LDJ, LFG, LCM, DJR, DNK, DJC, DIO, JXM, DJG, DIS, DKZ

Prescription Use : No

Device Count : 1

Tanner Scientific® - 00850011007143 Catalog Number : TNR 10SG

Device Description : Tanner Scientific 10SG, 100/BTL, CLIA WAIVED, Tests for: Glucose, Bilirubin, Ket Tanner Scientific 10SG, 100/BTL, CLIA WAIVED, Tests for: Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocyte Esterase

Device Class :

Duns Number: 834472680

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Tanner Scientific® - 00850011007150 Catalog Number : TNR IFOB

Device Description : Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 20/BX

Device Class :

Duns Number: 834472680

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

Tanner Scientific® - 00850011007167 Catalog Number : TNR IFOB36

Device Description : Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 36/BX

Device Class :

Duns Number: 834472680

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

Tanner Scientific® - 00850011007174 Catalog Number : TNR HCGCOMBO

Device Description : Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,P Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,Pregnancy Urine/Serum Combo 50BX

Device Class :

Duns Number: 834472680

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 1

Vacuflow™ - 00850011007181 Catalog Number : MED 5025

Device Description : Butterfly, Vacuflow non-safety, w/adapter 25G 12" tubing 50/bx

Device Class :

Duns Number: 834472680

Premarket Exempt : No

Product Code : JKA

Prescription Use : No

Device Count : 1

Vacuflow™ - 00850011007198 Catalog Number : MED 5221

Device Description : Vacuflow Butterfly Safety Luer Adapter 21g; 50bx

Device Class :

Duns Number: 834472680

Premarket Exempt : No

Product Code : JKA

Prescription Use : No

Device Count : 1

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