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STANBIO LABORATORY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16164871616487STANBIO LABORATORY1Y2026-01-011261 NORTH MAIN ST. Boerne TX US 78006

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
00657498000434Albumin LiquiColor® - For the Quantitative Colorimetric Determination of Albumin in Serum or Plasma.18005315535stanbiolab@ekfdiagnostics.com
00657498000847Glycated Serum Protein (GSP) LiquiColor® - Stanbio Glycated Serum Protein (GSP) Assay in conjunction with Stanbio Glycated Serum Protein calibrator, are intended for the quantitative determination of glycated serum proteins (GSP; glycated albumin; fructosamine) in serum. The measurement of glycated serum proteins is useful for monitoring diabetic patients.18005315535stanbiolab@ekfdiagnostics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
807201025988275K974429RAPET CRPDCN1998-02-18
807201993984795K974370RAPET RFDHR1998-02-17
807201206846545K972155CREATINE KINASE (CK)CGS1997-07-17
807201561576227K962418UREA NITROGEN (BUN) LIQUI-UVCDQ1996-12-26
807201893301333K952385HEMA-TROL Q-CHECKJJY1995-09-25
807201839654089K942958CREATINE KINASE MB DETERMINATION (UV)JHW1994-11-21
807201907945340K941313STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SETCJE1994-05-17
807201531114173K934701REAGENTS FOR COBAS ISE MODULEJIX1993-12-02
807201417449132K924248ACCUTEX SLE LATEX TESTLJM1992-11-02
807202030360680K921625CALCIUM-ARSENAZO III REAGENT SETCIC1992-05-13
807201224215388K911075COLOSCREENKHE1991-07-03
807202053130650K910108GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIEDJIN1991-03-04
807201375339888K905651KINETIC AMYLASE DETERMINATIONJFJ1991-01-31
807202054097237K883170STANBIO MAGNESIUM TEST SET, CAT. NO 0130JGJ1989-02-07
807201056670963K882938STAT FAX(TM)JJQ1988-09-09
807201380673816K880576RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)CJY1988-06-10
807201272493767K880144STANBIO SYPHILIS RPR TEST, NO. 1170GMQ1988-05-23
807201118186481K871456ULTRA-VIOLET GLUCOSE REAGENT KITCFR1987-04-29
807201691589860K862556SANDARE GLYCOHEMOGLOBIN PROCEDURELCP1986-08-08
807201980441685K832159UNITIZED ENZYMATIC GLUCOSE TEST SETCGA1983-08-16
807201681243385K810055STANBIO BILIRUBIN TEST SETCIG1981-02-02
807201057455734K802832SANDARE GLYCOHEMOGLOBIN PROCEDURELCP1981-01-16
807201818751569K801422SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.LCP1980-07-08
807201647226730K781635CHLORIDE TEST SET, CAT.# 0210CHJ1978-10-03
807202021722210K771856DIR. QUANT. COLOR. DETERM. SERUM CREAT.CGX1977-11-03
807201195164590K200909Hemo Control (optional Add Pack Hemo Control DM)GKR2020-06-12
807201164199319K172173DiaSpect Tm, DiaSpect Tm CuvettesGKR2018-04-06
807201501837150K162297Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control SetPTF2017-04-18
807201978694457K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring SystemsNBW2016-11-10
807201866475353K120124FORESIGHT U120 URINE ANALYZERJIL2012-03-06
807201102768704K110188DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KITLCP2011-05-17
807201772256734K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMGKR2009-06-10
807201181290082K081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMGKR2008-07-18
807201736640006K070929ACON U120 URINE ANALYZER, MODEL U111-101KQO2007-07-30
807201343841830K061559ACON URINALYSIS REAGENT STRIPSCDM2006-08-11
807201610446725K050283CREATININE LIQUICOLORJFY2005-06-30
807202065700560K050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORJFM2005-06-30
807201206186774K042421URITEK 151 URINE ANALYZER, MODEL TC-151KQO2005-05-09
807201958489524K042362MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12KHS2004-12-27
807202072226707K042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)KTN2005-02-28
807202026879529K042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERJJE2005-03-14
807201730562052K040958PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240JJE2005-02-15
807201805214034K032482STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMGKR2003-10-24
807201270144072K031539HEMOGLOBIN A1C REAGENT SETLCP2003-08-06
807201739046633K024350ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICELYR2003-04-02
807202054298901K020378QUPID PLUS E.R.JHI2002-06-21
807202049121670K020138STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090KHG2002-02-11
807201986937884K010582ACON STREP A RAPID TEST STRIPGTY2001-05-07
807201601206410BK050056
807201403531253
807201985071988
807201006462635
807201012431776
807201036113166
807201091227799
807201105890460
807201183600001
807201203363487
807201222692076
807201237184589
807201263618374
807201275663208
807201282519333
807201340240240
807201396758483
807201396874820
807201399010498
807201407013461
807201424973693
807201430004934
807201467822961
807201470323725
807201473016004
807201544319690
807201604511583
807201616014162
807201740179541
807201777161913
807201853765796
807201864321973
807201872228757
807201920946513
807201937725137
807201970483685
807201981871545
807201999381331
807202032123304
807202038090668
807202041779947

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKR52020-06-12
LCP52011-05-17
KQO22007-07-30
JJE22005-03-14
PTF12017-04-18
NBW12016-11-10
JIL12012-03-06
CDM12006-08-11
JFM12005-06-30
JFY12005-06-30
KTN12005-02-28
KHS12004-12-27
LYR12003-04-02
JHI12002-06-21
KHG12002-02-11
GTY12001-05-07
DCN11998-02-18
DHR11998-02-17
CGS11997-07-17
CDQ11996-12-26
JJY11995-09-25
JHW11994-11-21
CJE11994-05-17
JIX11993-12-02
LJM11992-11-02
CIC11992-05-13
KHE11991-07-03
JIN11991-03-04
JFJ11991-01-31
JGJ11989-02-07
JJQ11988-09-09
CJY11988-06-10
GMQ11988-05-23
CFR11987-04-29
CGA11983-08-16
CIG11981-02-02
CHJ11978-10-03
CGX11977-11-03

PMN#

46 records. Showing 1-40. Next

GUDID#

STAT-Site WB Dual Analyte Measurement System - The EKF Diagnostics STAT-Site WB Dual Analyte Measurement System is intended for the quantitative measurement of B-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous whole blood, and for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and from venous, and neonatal whole blood.The EKF Diagnostics STAT-Site WB Dual Analyte Measurement System is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.The system should not be used for the diagnosis of or screening for diabetes.The EKF Diagnostics STAT-Site WB B-Ketone Test Strips are for use with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System to quantitatively measure B-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous whole blood.EKF Diagnostics STAT-Site WB Blood Glucose Test Strips are for use with EKF Diagnostics STAT-Site WB Dual Analyte Measurement System to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, and from venous and neonatal whole blood.

STANBIO LABORATORY, L.P.

2019-11-18

80 records. Showing 1-40. Next