GERMAINE LABORATORIES, INC

Address:11030 Wye Drive,SAN ANTONIO,TX,78217,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

System, Test, Blood Glucose, Over The Counter (NBW) (3) Test System, Nicotine, Cotinine, Metabolites (MRS) (3) Drug Mixture Control Materials (DIF) (2) Enzyme Immunoassay, Benzodiazipine (JXM) (1) Enzyme Immunoassay, Cannabinoids (LDJ) (1) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (1) Enzyme Immunoassay, Methadone (DJR) (1) Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (DIC) (1) Enzyme Immunoassay, Phencyclidine (LCM) (1) Enzyme Immunoassay, Propoxyphene (JXN) (1) Gas Chromatography, Methamphetamine (LAF) (1) Glucose Oxidase, Glucose (CGA) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) Enzyme Immunoassay, Opiates (DJG) (1) Enzyme Immunoassay, Amphetamine (DKZ) (1) Enzyme Immunoassay, Barbiturate (DIS) (1)

Premarket Exempt

No Yes

Clear

AIMSTRIP PLUS, GLUCOSE CONTROL SOLUTION - 00695684373122 Catalog Number :

Device Description : Blood glucose control solution for use with AimStrip® Plus Blood Glucose Test St Blood glucose control solution for use with AimStrip® Plus Blood Glucose Test Strips & meter for testing blood glucose levels

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : NBW, JJX

Prescription Use : Yes

Device Count : 2

AIMSTRIP PLUS BLOOD GLUCOSE METER, BOX KIT - 00695684373214 Catalog Number :

Device Description : A blood glucose meter for use with AimStrip® Plus Blood Glucose Test Strips for A blood glucose meter for use with AimStrip® Plus Blood Glucose Test Strips for testing blood glucose levels.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

AIMSTRIP PLUS, BLOOD GLUCOSE TEST STRIPS - 00695684373504 Catalog Number :

Device Description : Blood glucose test strips for use with AimStrip® Plus Blood Glucose Meter for te Blood glucose test strips for use with AimStrip® Plus Blood Glucose Meter for testing blood glucose levels.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 50

DOA POSITIVE CONTROL - 00695684400026 Catalog Number :

Device Description : Positive Control for Drugs of Abuse Tests

Device Class : 1

Duns Number: 176458115

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

DOA NEGATIVE CONTROL - 00695684400033 Catalog Number :

Device Description : Negative Control for Drugs of Abuse Tests

Device Class : 1

Duns Number: 176458115

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

AIMSTEP COTININE - 00695684400101 Catalog Number :

Device Description : Cassette test for nicotine

Device Class : 1

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : MRS

Prescription Use : Yes

Device Count : 1

AIMSTEP COTININE - 00695684400125 Catalog Number :

Device Description : Cassette test for nicotine

Device Class :

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : MRS

Prescription Use : Yes

Device Count : 2000

AIMSTEP COTININE - 00695684400156 Catalog Number :

Device Description : Cassette test for nicotine

Device Class :

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : MRS

Prescription Use : Yes

Device Count : 50

AIMSTRIP ALCOHOL SALIVA - 00695684400705 Catalog Number :

Device Description : Semi-quantitative test for blood alcohol concentration

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DIC

Prescription Use : Yes

Device Count : 30

SAFECUP III MULTIDRUG 10 - 00695684401054 Catalog Number :

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DJR, JXN, JXM, DIS, LCM, LDJ, DKZ, DIO, LAF, DJG

Prescription Use : Yes

Device Count : 25

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