GERMAINE LABORATORIES, INC

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

Antigens, Nontreponemal, All (GMQ) (1) Antigens, Slide And Tube, Francisella Tularensis (GSL) (1) Antistreptolysin - Titer/Streptolysin O Reagent (GTQ) (1) Diazo Colorimetry, Bilirubin (CIG) (1) Helicobacter Pylori (LYR) (1) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) System, Test, Blood Glucose, Over The Counter (NBW) (1) System, Test, C-Reactive Protein (DCN) (1) System, Test, Rheumatoid Factor (DHR) (1)

Premarket Exempt

No Yes

Clear

FRANCISELLA TULARENSIS ANTIGEN - 00695684017033 Catalog Number :

Device Description : Francisella Tularensis Antigens are intended for the detection of bacterial aggl Francisella Tularensis Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GSL

Prescription Use : Yes

Device Count : 1

AIMTAB KETONE TABLETS - 00695684131005 Catalog Number :

Device Description : Tablet test for the detection of ketones (acetoacetic acid and acetone) in urine Tablet test for the detection of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. Similar to Acetest, trademark used by Bayer Healthcare, LLC.

Device Class :

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : JIN

Prescription Use : Yes

Device Count : 100

KETONE SERUM CONTROLS - 00695684131128 Catalog Number :

Device Description : Ketone controls for use with ketone tests, 1 Positive and 1 Negative

Device Class : 1

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

AIMTAB BILIRUBIN TABLETS - 00695684132002 Catalog Number :

Device Description : AimTab™ Bilirubin Tablets will detect as little as 0.05 to 0.1 mg/dL (0.8 to 1.7 AimTab™ Bilirubin Tablets will detect as little as 0.05 to 0.1 mg/dL (0.8 to 1.7 µmol/L) bilirubin in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : CIG

Prescription Use : Yes

Device Count : 100

AIM ASO TEST - 00695684310509 Catalog Number :

Device Description : Latex test for Anti-streptolysin O

Device Class :

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GTQ

Prescription Use : Yes

Device Count : 50

AIM CRP TEST - 00695684321000 Catalog Number :

Device Description : Latex slide test for C Reactive Protein

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DCN

Prescription Use : Yes

Device Count : 100

AIMSTEP H. PYLORI - 00695684330200 Catalog Number :

Device Description : A rapid cassette test for the qualitative detection of Helicobabacter pylori in A rapid cassette test for the qualitative detection of Helicobabacter pylori in serum, plasma, or whole blood.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : LYR

Prescription Use : Yes

Device Count : 20

AIM RF TEST - 00695684351007 Catalog Number :

Device Description : Latex test for Rheumatoid Factor

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 100

AIM RPR TEST - 00695684365004 Catalog Number :

Device Description : Test for reagin antibodies in serum or plasma

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 500

AIMSTRIP PLUS LANCETS - 00695684373115 Catalog Number :

Device Description : Lancets (sterile) for use with Blood Glucose Test Strips & meter for testing blo Lancets (sterile) for use with Blood Glucose Test Strips & meter for testing blood glucose levels

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : NBW

Prescription Use : Yes

Device Count : 100

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