[ Edit this Company] FDA-Registered Company Profile for GERMAINE LABORATORIES, INC. FDA-Supplied Establishment Information: Establishment Registration Number: 1649661 Company Name: GERMAINE LABORATORIES, INC. Also Known As: DETEKTA DIAGNOSTICS Address: 4139 GARDENDALE CENTER, Address 2: SUITE 101 City: SAN ANTONIO State TX Zip / Postal Code: 78229 County: BEXAR Country: US Establishment Operation Code(s): MM - Manufacturer MS - Specification Developer RR - Repackager/Relabeller Establishment Status Code: A - Active Year of Most Recent Initial or Annual Registration: 2007 FDA-Supplied Owner/Operator Information: Owner/Operator Number: 9031523 Company Name: GERMAINE LABORATORIES, INC. Address: 4139 GARDENDALE CENTER, Address 2: SUITE 101 City: SAN ANTONIO State: TX Zip / Postal Code: 78229 Country: US Owner/Operator Phone: 210-692-4192 FDA-Supplied Official Correspondent Information: Official Correspondent Name: MS. AMY CARR Company Name: GERMAINE LABORATORIES, INC. Address: 4139 GARDENDALE CENTER, Address 2: SUITE 101 City: SAN ANTONIO State: TX Zip / Postal Code: 78229 Country: US Official Corespondent Phone Number: 210-692-4192 Disputed Establishment Information: Address: 11030 WYE DRIVE City: SAN ANTONIO State: TX Zip: 78217 Disputed Owner/Operator Information: Address: 11030 WYE DRIVE City: SAN ANTONIO State Code: TX Zip: 78217 Disputed Official Correspondent Information: Official Correspondent Name: MS. AMY MACCRIND Address: 11030 WYE DRIVE City: SAN ANTONIO State Code: TX Zip Code: 78217 Other Establishment Information: Establishment Phone: Fax: General Email: Web Site: http://www.GERMAINELABS.COM Company Brochure: Keywords: pregnancy, test, urinalysis, febrile, occult blood, mono, ovulation, lateral flow, strep a, Company Description: All products sold by Germaine® Laboratories, Inc. are manufactured under strict quality control through cGMP (Good Manufacturing Practices) as overseen by the FDA. Our facility has also been approved to the Quality Management System Standards of ISO 13485:2003 and is applicable to the manufacture of In-Vitro diagnostic tests and reagents for professional, point of care, and self-test use for pregnancy, ovulation, urinalysis, drugs of abuse, serology, and strep products. These certifications attest to the quality standards set and achieved for the manufacture of the entire Germaine Laboratories product line. Services Offered: About Us: Founded in 1990 in San Antonio, Texas, the company incorporated and became Germaine® Laboratories, Inc. in 1997. That same year was also a landmark year in the growth of the Germaine® Laboratories, Inc., when we completed our initial clinical trials for the AccuHome® urine pregnancy test and received our first 510(k) clearance from the Food & Drug Administration (FDA). Over the past 14 years our product lines have grown to include diagnostic tests for pregnancy, drugs of abuse, febrile antigens, fecal occult blood, H. pylori, ovulation, serology, strep A and urinalysis. Our product line includes the brand names AccuHome®, Aim™, AimScreen™, AimStep®, AimStrip®, Compliance Gold®, CellFix™, SafeCup™ and StrepAim®. Differentiation: FDA-Registered Products Offered by GERMAINE LABORATORIES, INC. Common Device Name Proprietary Device Name 1 FRANCISELLA TULARENSIS FRANCISELLA TULARENSIS ANTISERUM 2 FRANCISELLA TULARENSIS ANTIGEN FRANCISELLA TULARENSIS ANTIGEN 3 H. PYLORI TEST DEVICE, H. PYLORI DIPSTICK TEST AIMSTEP, AIMSTICK 4 INFECTIOUS MONONUCLEOSIS IMMUNOLOGICAL TEST SYSTEM AIMSTEP MONO, AIMSTICK MONO 5 PROPOXYPHENE AIM SCREEN 6 THC MARIJUANA AIMSCREEN THC 7 VARIOUS ANTISERUM, POSITIVE AND NEGATIVE FEBRILE ANTIGEN CONTROL SERUM PRODUCTS MULTIPLE PRODUCT NAMES 8 VARIOUS KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER PRODUCTS MULTIPLE PRODUCT NAMES 9 VARIOUS SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN PRODUCTS MULTIPLE PRODUCT NAMES 10 VARIOUS TYPES AIMSCREEN & MULTIDRUG 11 VARIOUS TYPES MULTIPLE PRODUCT NAMES 12 VARIOUS TYPES MULTIPLE PRODUCT NAMES 13 VARIOUS TYPES MULTIPLE PRODUCT NAMES 14 VARIOUS TYPES MULTIPLE PRODUCT NAMES 15 VARIOUS TYPES AIM SCREEN & MULTIDRUG 16 VARIOUS TYPES OF BRUCELLA ANTISERA BRUCELLA ANTISERUM 17 VARIOUS TYPES OF PROTEUS ANTISERA PROTEUS POLY ANTISERUM 18 VARIOUS TYPES OF SALMONELLA ANTISERA MULTIPLE PRODUCT NAMES 19 VARIOUS TYPES, AMPHETAMINES TESTS AIMSCREEN 20 VARIOUS TYPES, BARBITURATE AIMSCREEN & MULTIDRUG 21 VARIOUS TYPES, BENZODIAZIPINE AIMSCREEN & MULTIDRUG 22 VARIOUS TYPES, CANNABINOIDS & THC AIMSCREEN & MULTIDRUG 23 VARIOUS TYPES, COCAINE TESTS AIMSCREEN 24 VARIOUS TYPES, METHADONE AIMSCREEN & MULTIDRUG 25 VARIOUS TYPES, OPIATES TESTS AIMSCREEN & MULTIDRUG 26 VARIOUS TYPES, OVULATION TEST ACCUHOME & AIMSTEP 27 VARIOUS TYPES, PHENCYCLIDINE TESTS AIMSCREEN, & MULTIDRUG 28 VARIOUS TYPES, STREPTOCOCCUS TEST KIT STREPAIM All FDA-Registered products for this company are displayed above. Other Products Offered by GERMAINE LABORATORIES, INC.:  No products have been listed by this company. Services Offered by the GERMAINE LABORATORIES, INC.: No services have been listed by this company. Additional Contact Information for GERMAINE LABORATORIES, INC.: There is no additional contact information for this company. [ About ] [ Contact ] [ Login ] © 2025 Medevnet.com - All Rights Reserved