FDA.reportPublic FDA data

GENBIO

Matched from indexed company URL: GenBio

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20271132027113GENBIO1N2026-01-0115222 AVE. OF SCIENCE Suite A San Diego CA US 92128

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00613745002859AlleleSEQR® HLA-A PCR/Sequencing kit (25) - 07K38-018585929300orders@genbio.com
00613745003870NGSgo®-AmpX v2 Enhancer - 707000118585929300orders@genbio.com
00613745003887NGSgo®-LibrX End Prep Enzyme - 200200518585929300orders@genbio.com
00613745003894NGSgo®-LibrX End Prep Buffer - 200200528585929300orders@genbio.com
00613745003900NGSgo®-LibrX Ligase Mix - 200200538585929300orders@genbio.com
00613745003917NGSgo®-LibrX Ligation Enhancer - 200200548585929300orders@genbio.com
00613745003924GenDx-LongMix - 500765218585929300orders@genbio.com
00613745003931NGSgo-AmpX v3 HLA-DRB3/4/5 (96) - 73337628585929300orders@genbio.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
347551067800876K974244IMMUNODOT MONO-M TESTLSE1998-09-22
347551139164271K974226IMMUNODOT MONO-G TESTLSE1998-09-22
347551894816299K973941IMMUNOWELL EBNA IGG TESTLLM1998-08-10
347551981374394K973940IMMUNOWELL EBV VCA IGG TESTLSE1998-08-10
347551123213297K973939IMMUNOWELL VCA IGM TESTLJN1998-08-10
347551695126382K971591INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)LSQ1998-03-13
347552005737482K963055IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120LJZ1997-05-02
347551206546607K963054IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)LJZ1997-05-05
347552043201716K953683MMUNO DOT BORRELIA DOT BLOT M TESTLSR1996-05-03
347551913583463K953682IMMUNO DOT BORRELIA DOT BLOT G TESTLSR1996-05-03
347551291590116K924843IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANELLLL1992-12-01
347551022883181K920569INDXTM DIP-S-TICKSTMLSQ1993-02-09
347551839647671K920401IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TESTMID1992-08-20
347551701657832K920400IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TESTMID1992-08-20
347551863155528K914801IMMUNOWELL DSDNA ANTIBODY TESTDHC1991-12-09
347551946242917K911850IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TESTLKO1991-05-07
347551332571057K911849IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TESTLKO1991-05-07
347551521329842K911848IMMUNOWELL RNP/SM ANTIBODY TESTLKP1991-05-07
347551854187958K911627IMMUNODOT BORRELIA (LYME) TESTLSR1992-04-08
347552033342066K911590IMMUNOWELL BORRELIA (LYME)TESTLSR1991-12-20
347552026706366K905486IMMUNOWELL TPO (MICROSOME) TESTJNL1991-01-03
347551099478537K905485IMMUNOWELL THYROGLOBULIN TESTJZO1991-01-25
347551123218023K903843IMMUNODOT THYROID AUTOIMMUNITY PANELJNL1990-10-02
347551407810680K903047IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4LLL1990-08-09
347551212453431K901597INDX DIP S TICKSLSQ1990-12-21
347551819464735K896347IMMUNODOT AUTOIMMUNE SCREENING PANEL 1LJM1989-12-05
347551189302631K884898IMMUNODOT TORCH TEST RUBELLALFX1989-02-03
347551032802012K861123THE GOLDEN QUAD TEST (CMV)GQI1987-02-02
347552007191521K861122THE GOLDEN QUAD TEST (TOXO)LJK1987-02-02
347551675773602K861120THE GOLDEN QUAD TEST (HSV)GQO1987-02-02
347551178974828K803134TOXOPLASMA GONDII SEROLOGICAL REAGENTSGLZ1981-01-29
347551173568330K151061Cornea ColdLYX2015-08-06
347552058730684K010301IMMUNOWELL EA (D) IGG TESTLSE2001-06-11
347552026249679K002024PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXAGRY2000-11-22
347551132948060
347551265646288
347551340079806
347551370598706
347551470424157
347551495253539
347551556299982
347551654444020
347551797971668
347551875696880
347551973873488
347551999373340
347552045322529
347551365124085
347551612112773
347551830681510
347551898532255
347552001276086

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LSE42001-06-11
LSR41996-05-03
LSQ31998-03-13
LJZ21997-05-05
LLL21992-12-01
MID21992-08-20
LKO21991-05-07
JNL21991-01-03
LYX12015-08-06
GRY12000-11-22
LJN11998-08-10
LLM11998-08-10
DHC11991-12-09
LKP11991-05-07
JZO11991-01-25
LJM11989-12-05
LFX11989-02-03
LJK11987-02-02
GQI11987-02-02
GQO11987-02-02
GLZ11981-01-29

NDC#

PMN#

Applications#

GUDID#

168 records. Showing 1-40. Next