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

Enzyme Immunoassay, Opiates (DJG) (7) Enzyme Immunoassay, Cannabinoids (LDJ) (6) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (6) Enzyme Immunoassay, Amphetamine (DKZ) (6) Gas Chromatography, Methamphetamine (LAF) (6) Enzyme Immunoassay, Phencyclidine (LCM) (2) Enzyme Immunoassay, Benzodiazipine (JXM) (1) Enzyme Immunoassay, Methadone (DJR) (1)

Premarket Exempt

No Yes

Clear

SAFECUP II MULTIDRUG N5 - 00695684454555 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for easy photocopying. Tests for COC, AMP, THC, OPI, PCP (cocaine, amphetamine, marijuana, opiates, Phencyclidine).

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : LCM, DJG, DKZ, DIO, LDJ

Prescription Use : Yes

Device Count : 25

SAFECUP II MULTIDRUG 5 - 00695684454654 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-sid Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for easy photocopying. Tests for COC, mAMP, AMP, THC, OPI, (cocaine, methamphetamine, amphetamine, marijuana, opiates).

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DKZ, DJG, LAF, DIO, LDJ

Prescription Use : Yes

Device Count : 25

SAFECUP III MULTIDRUG 5 - 00695684454753 Catalog Number :

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : LDJ, DJG, DKZ, LAF, DIO

Prescription Use : Yes

Device Count : 25

SAFECUP III MULTIDRUG N5 - 00695684454852 Catalog Number :

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : LDJ, LCM, DJG, DKZ, DIO

Prescription Use : Yes

Device Count : 25

AIMSCREEN MULTIDRUG 5 - 00695684456252 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine ( Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Marijuana (THC), Opiates (OPI).

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DKZ, DJG, LAF, DIO, LDJ

Prescription Use : Yes

Device Count : 25

AIMSCREEN MTD - 00695684461256 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of Methadone (MTD) in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DJR

Prescription Use : Yes

Device Count : 25

AIMSCREEN MULTIDRUG 6 - 00695684463250 Catalog Number :

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : JXM, DKZ, DJG, LAF, DIO, LDJ

Prescription Use : Yes

Device Count : 25

AIMSCREEN MET - 00695684471255 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of Methamphetamine (MET) in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : LAF

Prescription Use : Yes

Device Count : 25

AIMSCREEN MOP - 00695684481254 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of Opiate (OPI) in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 25

AIMSCREEN MDMA - 00695684482251 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of Ecstasy (MDMA) in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : LAF

Prescription Use : Yes

Device Count : 25

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