Germaine Laboratories Inc

FDA Filings

This page includes the latest FDA filings for Germaine Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1649661
• FEI Number: 3001451797
• Name: GERMAINE LABORATORIES, INC.
• Owner & Operator: GERMAINE LABORATORIES, INC.
• Contact Address: 11030 Wye Drive ; San Antonio TX 78217 US
• Official Correspondent:
  • Craig A Waldrip
  • x-210-6924192-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 11030 Wye Drive ; SAN ANTONIO, TX 78217 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Reprocess Single-Use Device
  • Remanufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 10695684423381 GERMAINE LABORATORIES, INC	AimScreen Fentanyl	2024-04-09
GUDID 00695684971014 GERMAINE LABORATORIES, INC	Pregcolor Premium	2023-08-17
GUDID 00695684893019 GERMAINE LABORATORIES, INC	Pregcolor Plus	2023-08-17
GUDID 00695684444310 GERMAINE LABORATORIES, INC	SAFECUP III 13 PANEL	2022-08-25
GUDID 00695684410117 GERMAINE LABORATORIES, INC	SAFECUP III MULTIDRUG 11	2022-08-25
PMN K024360 | LYR GERMAINE LABORATORIES, INC.	AimStep H. Pylori	2020-03-19
GUDID 00695684957018 GERMAINE LABORATORIES, INC	Mosie Baby Pregnancy Test	2020-01-31
GUDID 00695684754075 GERMAINE LABORATORIES, INC	Mosie Baby Ovulation Test	2020-01-31
GUDID 06956848940166 GERMAINE LABORATORIES, INC	Mosie Baby Pregnancy Test	2019-10-29
GUDID 06956847540756 GERMAINE LABORATORIES, INC	Mosie Baby Ovulation Test	2019-10-29
GUDID 00695684591007 GERMAINE LABORATORIES, INC	AIMSTRIP US-9	2019-10-07
GUDID 00695684552008 GERMAINE LABORATORIES, INC	AIMSTRIP US-5B	2019-10-07
GUDID 00695684551001 GERMAINE LABORATORIES, INC	AIMSTRIP US-5	2019-10-07
GUDID 00695684544003 GERMAINE LABORATORIES, INC	AIMSTRIP US-4	2019-10-07
GUDID 00695684511111 GERMAINE LABORATORIES, INC	AIMSTRIP US-11	2019-10-07
GUDID 00695684511005 GERMAINE LABORATORIES, INC	AIMSTRIP 10-SG	2019-10-07
GUDID 00695684730253 GERMAINE LABORATORIES, INC	STREPAIM	2019-03-11
GUDID 00695684131128 GERMAINE LABORATORIES, INC	KETONE SERUM CONTROLS	2019-03-11
GUDID 00695684521004 GERMAINE LABORATORIES, INC	AIMSTRIP US-2	2018-03-29
GUDID 00695684513207 GERMAINE LABORATORIES, INC	BARCODE READER FOR AIMSTRIP URINE ANALYZERS	2018-03-29
GUDID 00695684512347 GERMAINE LABORATORIES, INC	PRINTER PEEL AND STICK PAPER	2018-03-29
GUDID 00695684512248 GERMAINE LABORATORIES, INC	PRINTER PAPER ROLLS	2018-03-29
GUDID 00695684511616 GERMAINE LABORATORIES, INC	UA LIQUID CONTROLS 6X10ML	2018-03-29
GUDID 00695684511425 GERMAINE LABORATORIES, INC	UA DIPTUBE CONTROLS 4X12ML	2018-03-29
GUDID 00695684511203 GERMAINE LABORATORIES, INC	AIMSTRIP URINE ANALYZER	2018-03-29
GUDID 00695684511159 GERMAINE LABORATORIES, INC	UA LIQUID CONTROLS 2X5ML	2018-03-29
GUDID 00695684511128 GERMAINE LABORATORIES, INC	UA DIPTUBE CONTROLS 2X12ML	2018-03-29
GUDID 00695684511104 GERMAINE LABORATORIES, INC	AIMSTRIP URINE AUTO ANALYZER	2018-03-29
GUDID 00695684501310 GERMAINE LABORATORIES, INC	AIMSTRIP US-N	2018-03-29
GUDID 00695684501211 GERMAINE LABORATORIES, INC	AIMSTRIP US-K	2018-03-29
GUDID 00695684501006 GERMAINE LABORATORIES, INC	AIMSTRIP US-G	2018-03-29
GUDID 00695684495251 GERMAINE LABORATORIES, INC	AIMSCREEN PPX	2018-03-29
GUDID 00695684494254 GERMAINE LABORATORIES, INC	AIMSCREEN OXY	2018-03-29
GUDID 00695684491253 GERMAINE LABORATORIES, INC	AIMSCREEN PCP	2018-03-29
GUDID 00695684482251 GERMAINE LABORATORIES, INC	AIMSCREEN MDMA	2018-03-29
GUDID 00695684481254 GERMAINE LABORATORIES, INC	AIMSCREEN MOP	2018-03-29
GUDID 00695684471255 GERMAINE LABORATORIES, INC	AIMSCREEN MET	2018-03-29
GUDID 00695684463250 GERMAINE LABORATORIES, INC	AIMSCREEN MULTIDRUG 6	2018-03-29
GUDID 00695684461256 GERMAINE LABORATORIES, INC	AIMSCREEN MTD	2018-03-29
GUDID 00695684456252 GERMAINE LABORATORIES, INC	AIMSCREEN MULTIDRUG 5	2018-03-29
GUDID 00695684454852 GERMAINE LABORATORIES, INC	SAFECUP III MULTIDRUG N5	2018-03-29
GUDID 00695684454753 GERMAINE LABORATORIES, INC	SAFECUP III MULTIDRUG 5	2018-03-29
GUDID 00695684454654 GERMAINE LABORATORIES, INC	SAFECUP II MULTIDRUG 5	2018-03-29
GUDID 00695684454555 GERMAINE LABORATORIES, INC	SAFECUP II MULTIDRUG N5	2018-03-29
GUDID 00695684451257 GERMAINE LABORATORIES, INC	AIMSCREEN THC	2018-03-29
GUDID 00695684442255 GERMAINE LABORATORIES, INC	AIMSCREEN TCA	2018-03-29
GUDID 00695684441258 GERMAINE LABORATORIES, INC	AIMSCREEN OPI	2018-03-29
GUDID 00695684431259 GERMAINE LABORATORIES, INC	AIMSCREEN COC	2018-03-29
GUDID 00695684423254 GERMAINE LABORATORIES, INC	AIMSCREEN BZO	2018-03-29
GUDID 00695684421250 GERMAINE LABORATORIES, INC	AIMSCREEN BAR	2018-03-29
GUDID 00695684420253 GERMAINE LABORATORIES, INC	AIMSCREEN BUP	2018-03-29
GUDID 00695684415259 GERMAINE LABORATORIES, INC	SAFECUP II MULTIDRUG 10	2018-03-29
GUDID 00695684415228 GERMAINE LABORATORIES, INC	SAFECUP II MULTIDRUG 12	2018-03-29
GUDID 00695684415136 GERMAINE LABORATORIES, INC	SAFECUP III MULTIDRUG 12	2018-03-29
GUDID 00695684411251 GERMAINE LABORATORIES, INC	AIMSCREEN AMP	2018-03-29
GUDID 00695684409258 GERMAINE LABORATORIES, INC	AIMSCREEN MULTIDRUG 9	2018-03-29
GUDID 00695684405250 GERMAINE LABORATORIES, INC	AIMSCREEN MULTIDRUG N5	2018-03-29
GUDID 00695684404253 GERMAINE LABORATORIES, INC	AIMSCREEN MULTIDRUG 4	2018-03-29
GUDID 00695684403256 GERMAINE LABORATORIES, INC	AIMSCREEN MULTIDRUG 3	2018-03-29
GUDID 00695684402259 GERMAINE LABORATORIES, INC	AIMSCREEN MULTIDRUG 2	2018-03-29
GUDID 00695684401351 GERMAINE LABORATORIES, INC	AIMSCREEN MULTIDRUG 12	2018-03-29
GUDID 00695684401252 GERMAINE LABORATORIES, INC	AIMSCREEN MULTIDRUG 10	2018-03-29
GUDID 00695684401054 GERMAINE LABORATORIES, INC	SAFECUP III MULTIDRUG 10	2018-03-29
GUDID 00695684400705 GERMAINE LABORATORIES, INC	AIMSTRIP ALCOHOL SALIVA	2018-03-29
GUDID 00695684400156 GERMAINE LABORATORIES, INC	AIMSTEP COTININE	2018-03-29
GUDID 00695684400125 GERMAINE LABORATORIES, INC	AIMSTEP COTININE	2018-03-29
GUDID 00695684400101 GERMAINE LABORATORIES, INC	AIMSTEP COTININE	2018-03-29
GUDID 00695684400033 GERMAINE LABORATORIES, INC	DOA NEGATIVE CONTROL	2018-03-29
GUDID 00695684400026 GERMAINE LABORATORIES, INC	DOA POSITIVE CONTROL	2018-03-29
GUDID 00695684373504 GERMAINE LABORATORIES, INC	AIMSTRIP PLUS, BLOOD GLUCOSE TEST STRIPS	2018-03-29
GUDID 00695684373214 GERMAINE LABORATORIES, INC	AIMSTRIP PLUS BLOOD GLUCOSE METER, BOX KIT	2018-03-29
GUDID 00695684373122 GERMAINE LABORATORIES, INC	AIMSTRIP PLUS, GLUCOSE CONTROL SOLUTION	2018-03-29
GUDID 00695684373115 GERMAINE LABORATORIES, INC	AIMSTRIP PLUS LANCETS	2018-03-29
GUDID 00695684365004 GERMAINE LABORATORIES, INC	AIM RPR TEST	2018-03-29
GUDID 00695684351007 GERMAINE LABORATORIES, INC	AIM RF TEST	2018-03-29
GUDID 00695684330200 GERMAINE LABORATORIES, INC	AIMSTEP H. PYLORI	2018-03-29
GUDID 00695684321000 GERMAINE LABORATORIES, INC	AIM CRP TEST	2018-03-29
GUDID 00695684310509 GERMAINE LABORATORIES, INC	AIM ASO TEST	2018-03-29
GUDID 00695684132002 GERMAINE LABORATORIES, INC	AIMTAB BILIRUBIN TABLETS	2018-03-29
GUDID 00695684131005 GERMAINE LABORATORIES, INC	AIMTAB KETONE TABLETS	2018-03-29
GUDID 00695684017033 GERMAINE LABORATORIES, INC	FRANCISELLA TULARENSIS ANTIGEN	2018-03-29
GUDID 00695684017026 GERMAINE LABORATORIES, INC	FRANCISELLA TULARENSIS ANTISERUM	2018-03-29
GUDID 00695684016111 GERMAINE LABORATORIES, INC	SALMONELLA O POLY POSITIVE CONTROL	2018-03-29
GUDID 00695684016067 GERMAINE LABORATORIES, INC	SALMONELLA H POLY POSITIVE CONTROL	2018-03-29
GUDID 00695684016012 GERMAINE LABORATORIES, INC	FEBRILE NEGATIVE CONTROL	2018-03-29
GUDID 00695684016005 GERMAINE LABORATORIES, INC	FEBRILE POSITIVE CONTROL	2018-03-29
GUDID 00695684015039 GERMAINE LABORATORIES, INC	SALMONELLA O GROUP D ANTIGEN	2018-03-29
GUDID 00695684015022 GERMAINE LABORATORIES, INC	SALMONELLA O GROUP C ANTIGEN	2018-03-29
GUDID 00695684015015 GERMAINE LABORATORIES, INC	SALMONELLA O GROUP B ANTIGEN	2018-03-29
GUDID 00695684015008 GERMAINE LABORATORIES, INC	SALMONELLA O GROUP A ANTIGEN	2018-03-29
GUDID 00695684014032 GERMAINE LABORATORIES, INC	SALMONELLA H d ANTIGEN	2018-03-29
GUDID 00695684014025 GERMAINE LABORATORIES, INC	SALMONELLA H c ANTIGEN	2018-03-29
GUDID 00695684014018 GERMAINE LABORATORIES, INC	SALMONELLA H b ANTIGEN	2018-03-29
GUDID 00695684014001 GERMAINE LABORATORIES, INC	SALMONELLA H a ANTIGEN	2018-03-29
GUDID 00695684013035 GERMAINE LABORATORIES, INC	PROTEUS POLY ANTISERUM	2018-03-29
GUDID 00695684012021 GERMAINE LABORATORIES, INC	PROTEUS OX19 ANTIGEN	2018-03-29
GUDID 00695684012014 GERMAINE LABORATORIES, INC	PROTEUS OX2 ANTIGEN	2018-03-29
GUDID 00695684012007 GERMAINE LABORATORIES, INC	PROTEUS OXK ANTIGEN	2018-03-29
GUDID 00695684011000 GERMAINE LABORATORIES, INC	BRUCELLA ABORTUS ANTISERUM	2018-03-29
GUDID 00695684010027 GERMAINE LABORATORIES, INC	BRUCELLA MELITENSIS ANTIGEN	2018-03-29
GUDID 00695684010003 GERMAINE LABORATORIES, INC	BRUCELLA ABORTUS ANTIGEN	2018-03-29
MRS GERMAINE LABORATORIES, INC.	Universal Flat Nose Pliers	2013-02-26
MRS GERMAINE LABORATORIES, INC.	Pliers, Surgical (Various)	2013-02-26
HTC GERMAINE LABORATORIES, INC.	Universal Flat Nose Pliers	2010-04-01
HTC GERMAINE LABORATORIES, INC.	Pliers, Surgical (Various)	2010-04-01
PMN K051727 GERMAINE LABORATORIES, INC.	AIMSTICK URINE REAGENT STRIPS	2005-10-26
CEP GERMAINE LABORATORIES, INC.	Mosie Baby Ovulation Test	1999-08-19
CEP GERMAINE LABORATORIES, INC.	AimStrip	1999-08-19
CEP GERMAINE LABORATORIES, INC.	AimStep	1999-08-19
CEP GERMAINE LABORATORIES, INC.	AccuHome	1999-08-19
PMN K991369 GERMAINE LABORATORIES, INC.	ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY	1999-05-10
PMN K981165 GERMAINE LABORATORIES, INC.	AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST	1998-04-16
PMN K980531 GERMAINE LABORATORIES, INC.	AIMSTEP PREGNANCY	1998-03-06
PMN K974512 GERMAINE LABORATORIES, INC.	AIMSTICK PBD COMBO PREGNANCY	1998-01-02
PMN K974368 GERMAINE LABORATORIES, INC.	AIMSTICK PBD PREGNANCY	1998-01-02
PMN K973825 GERMAINE LABORATORIES, INC.	MIDSTREAM HOME REGNANCY TEST	1997-12-19

Related Finance Registrations

NCAGE Code	3VAR0	GERMAINE LABORATORIES INC
CAGE Code	3VAR0	GERMAINE LABORATORIES, INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091064791	Shanghai ,China (Mainland) -> Long Beach, California	RAPID DIAGNOSTIC TEST	80 PKG
2020082559271	Shanghai ,China (Mainland) -> Long Beach, California	DIAGNOSTIC TEST, MOS PREGNANCY OVULATION POUC H	17 CTN
2020081716184	Pusan,South Korea -> Long Beach, California	GERMAINE IFOB TEST	25 CTN
2020070739572	Shanghai ,China (Mainland) -> Long Beach, California	DIAGNOSTIC TESTS	22 CTN
2020052039836	Shanghai ,China (Mainland) -> Long Beach, California	DIAGNOSTIC TESTS, DOTEST FOIL POUCH, WORKSTAT ION	43 CTN
2020040444912	Shanghai ,China (Mainland) -> Long Beach, California	DIAGNOSTIC TESTS, DOTEST FOIL POUCH	26 CTN
2020033128465	Shanghai ,China (Mainland) -> Long Beach, California	DIAGNOSTIC TESTS	56 CTN
2020021330636	Nhava Sheva,India -> New York/Newark Area, Newark, New Jersey	189 TOP DISPOSABLE PLASTIC CASSETTE KB CDM 100 189 BOTTON DISPOSABLE PLASTIC CASSETTE KB CDM 100 DISPOSABLE PLASTIC CAP KB CDM 101	130 BOX