Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1649661

FEI Number

3001451797

Entity Name

GERMAINE LABORATORIES, INC.

City/State/Country

SAN ANTONIO, TX, US

Establishment Address

11030 Wye Drive, SAN ANTONIO, TX 78217, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

GERMAINE LABORATORIES, INC. (Owner Number: 9031523)

Owner / Operator Contact Address

11030 Wye Drive, San Antonio, TX 78217, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122553

PMA Number

N/A

All Registered Proprietary Names

AimStrip Xylazine AimScreen Fentanyl AimScreen Xylazine AimStrip Fentanyl FisherBrand 40B Urine Reagent Strips FisherBrand 2P Urine Reagent Strips FisherBrand 5P Urine Reagent Strips StrepAim Strep A Test Pregcolor Premium AimScreen Fentanyl FisherBrand Urine Analyzer AimStep H. Pylori SafeCup III 13-F AimStrip Mosie Baby Ovulation Test AimStep AccuHome Compliance Gold Mosie Baby Pregnancy Test SafeCup III 12-M AimStrip MACRE FisherBrand 2CE Urine Reagent Strips FisherBrand Thermal Printer Paper AimStrip Thermal Printer Paper AimStep

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2023-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-01-22
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2016-06-03
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2016-06-03
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2016-06-03
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2016-06-03
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2016-06-03
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2016-06-03
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2016-06-03
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2016-06-03
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2016-06-03
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2016-06-03
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2016-06-03
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2023-01-17
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2023-08-09
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2023-08-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2016-04-21
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2008-04-09
GSN	Antiserum, Positive And Negative Febrile Antigen Control Serum	Microbiology	Class 2	866.3085	1997-09-08
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2016-04-25
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2016-04-25
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2016-04-25
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2016-04-25
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2016-04-25
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2016-04-25
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2016-04-25
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2016-04-25
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2016-04-25
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2007-12-17
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2007-12-17
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2008-02-21
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2011-09-20
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2013-06-17
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2020-01-10
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2006-05-30
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2019-11-04
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2019-11-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-11-04
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2019-11-04
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-11-04
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2019-11-04
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2007-12-17
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2026-05-11
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2016-03-24
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2016-04-21
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2008-02-20
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-04-01
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-04-01
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2013-01-18
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2018-05-15
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2018-05-15
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2018-05-15
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2018-05-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2018-05-15
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2018-05-15
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2018-05-15
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2018-05-15
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2018-05-15
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2020-01-10
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2020-01-10
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2020-01-10
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2020-01-10
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2020-01-10
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2020-01-10
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2020-01-10
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2020-01-10
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2020-01-10
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2020-01-10
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2020-01-10
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2020-01-10
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2007-12-17
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2020-03-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2007-12-17
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2010-05-20
GNC	Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	1997-09-08
GSM	Antisera, Fluorescent, Brucella Spp.	Microbiology	Class 2	866.3085	1997-09-08
GSK	Antiserum, Francisella Tularensis	Microbiology	Class 2	866.3280	1997-09-08
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2007-12-17
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2025-05-14
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-05-14
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-05-14
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2025-05-14
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2025-05-14
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2025-05-14
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2025-05-14
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2025-05-14
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-05-14
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2025-05-14
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-05-14
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2007-12-17
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	1999-08-19
GSZ	Antigens, Febrile (Weil-Felix), All Groups	Microbiology	Class 1	866.3410	2018-06-14
GSY	Antisera, Fluorescent, All Globulins, Proteus Spp.	Microbiology	Class 1	866.3410	1997-09-08
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2023-09-18
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2007-12-17
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2007-12-17
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2026-04-07
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2026-04-07
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2026-04-07
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2026-04-07
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2026-04-07
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2026-04-07
NGI	Test, Morphine, Over The Counter	Clinical Toxicology	Class 2	862.3640	2026-04-07
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2026-04-07
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2026-04-07
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2026-04-07
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2026-04-07
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2026-04-07
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2007-12-17
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2007-12-17
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2025-03-31
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2025-03-31
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2007-12-17
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2001-12-17
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2013-01-18
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-01-18
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-01-18
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2016-04-20
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2022-09-13
GRL	Antigens, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	1997-09-08
PDA	Investigational Use Only - Clinical Chemistry	Unknown	Class N	N/A	2024-10-17
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2013-02-26
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2011-09-20
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2007-12-17
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2010-05-19
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2016-04-20
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2016-04-20

Official Correspondent

Craig Waldrip

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GERMAINE LABORATORIES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Related Recall Records

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1649661. Last updated year: 2026. Please use registration number 1649661 when referencing this establishment in official correspondence.