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

Automated Urinalysis System (KQO) (6) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (3) Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (JMT) (3) Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (JIL) (3) Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (CDM) (2) Dye-Indicator, Ph (Urinary, Non-Quant.) (CEN) (2) Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (JJB) (2) Blood, Occult, Colorimetric, In Urine (JIO) (2) Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (2) Test, Urine Leukocyte (LJX) (2) Refractometer For Clinical Use (JRE) (2) Urinalysis Controls (Assayed And Unassayed) (JJW) (1) Enzyme Immunoassay, Opiates (DJG) (1) Enzyme Immunoassay, Phencyclidine (LCM) (1) Enzyme Immunoassay, Propoxyphene (JXN) (1)

Premarket Exempt

No Yes

Clear

AIMSCREEN PCP - 00695684491253 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of Phencyclidine (PCP) in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : LCM

Prescription Use : Yes

Device Count : 25

AIMSCREEN OXY - 00695684494254 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of Oxycodone (OXY) in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 25

AIMSCREEN PPX - 00695684495251 Catalog Number :

Device Description : Lateral flow immunoassay for the detection of Propoxyphene (PPX) in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : JXN

Prescription Use : Yes

Device Count : 25

AIMSTRIP US-G - 00695684501006 Catalog Number :

Device Description : Dipstick reagent strips for the qualitative detection of Glucose in Urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KQO, JIL

Prescription Use : Yes

Device Count : 100

AIMSTRIP US-K - 00695684501211 Catalog Number :

Device Description : Dipstick reagent strips for the qualitative detection of Ketone in Urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : JIN, KQO

Prescription Use : No

Device Count : 100

AIMSTRIP US-N - 00695684501310 Catalog Number :

Device Description : Dipstick reagent strips for the qualitative detection of Nitrite in Urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : JMT, KQO

Prescription Use : Yes

Device Count : 100

AIMSTRIP 10-SG - 00695684511005 Catalog Number :

Device Description : Dipstick reagent strips for the qualitative detection of the following : Glucose Dipstick reagent strips for the qualitative detection of the following : Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in Urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 100

AIMSTRIP URINE AUTO ANALYZER - 00695684511104 Catalog Number :

Device Class : 1

Duns Number: 176458115

Premarket Exempt : No

Product Code : KQO

Prescription Use : Yes

Device Count : 1

AIMSTRIP US-11 - 00695684511111 Catalog Number :

Device Class :

Duns Number: 176458115

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 100

UA DIPTUBE CONTROLS 2X12ML - 00695684511128 Catalog Number :

Device Description : Controls used with AimStrip® Urine Reagent Strips

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : JJW

Prescription Use : Yes

Device Count : 2

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