Stanbio Laboratory FDA Filings

FDA Registration(s)

Registration Number	1616487
FEI Number	1616487
Name	STANBIO LABORATORY
Owner & Operator	STANBIO LABORATORY
Contact Address	1261 NORTH MAIN ST. -- Boerne TX 78006 US
Official Correspondent	Karen Golomb x-830-2490772-x
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	1261 NORTH MAIN ST. Boerne, TX 78006 US
Establishment Type	Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Device in the United States for Export Only

Registration Number	1832837
FEI Number	1832837
Name	EKF Life Sciences
Owner & Operator	STANBIO LABORATORY
Contact Address	1261 NORTH MAIN ST. -- Boerne TX 78006 US
Official Correspondent	Karen Golomb x-830-2490772-x
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	1814 Leer Dr ELKHART, IN 46514 US
Establishment Type	Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K090093 STANBIO LABORATORY	STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM	2009-06-10
PMN K081719 STANBIO LABORATORY	STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM	2008-07-18
PMN K050283 STANBIO LABORATORY	CREATININE LIQUICOLOR	2005-06-30
PMN K050266 STANBIO LABORATORY	DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR	2005-06-30
PMN K042169 STANBIO LABORATORY	STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER	2005-03-14
PMN K041155 STANBIO LABORATORY	WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY	2004-10-14
PMN K032936 STANBIO LABORATORY	DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR	2004-03-12
PMN K032932 STANBIO LABORATORY	DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR	2004-03-10
PMN K032482 STANBIO LABORATORY	STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM	2003-10-24
PMN K020378 STANBIO LABORATORY	QUPID PLUS E.R.	2002-06-21
PMN K974429 STANBIO LABORATORY	RAPET CRP	1998-02-18
PMN K974370 STANBIO LABORATORY	RAPET RF	1998-02-17
PMN K972155 STANBIO LABORATORY	CREATINE KINASE (CK)	1997-07-17
PMN K962418 STANBIO LABORATORY	UREA NITROGEN (BUN) LIQUI-UV	1996-12-26
PMN K941314 STANBIO LABORATORY	STANBIO ALT/GPT (LUQUI-UV) TEST SET	1994-07-20
PMN K941315 STANBIO LABORATORY	STANBIO Y-GT (LIQUICOLOR) TEST SET	1994-07-14
PMN K941313 STANBIO LABORATORY	STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET	1994-05-17
PMN K932049 STANBIO LABORATORY	STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020	1993-11-16
PMN K902204 STANBIO LABORATORY	STANBIO CSF/URINE TOTAL PROTEIN TEST SET	1990-08-22
PMN K893128 STANBIO LABORATORY	STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010	1989-07-25
PMN K883170 STANBIO LABORATORY	STANBIO MAGNESIUM TEST SET, CAT. NO 0130	1989-02-07
PMN K880144 STANBIO LABORATORY	STANBIO SYPHILIS RPR TEST, NO. 1170	1988-05-23
PMN K880467 STANBIO LABORATORY	STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR	1988-03-24
PMN K870746 STANBIO LABORATORY	STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715	1987-06-01
PMN K851278 STANBIO LABORATORY	ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870	1985-04-17
PMN K842544 STANBIO LABORATORY	STANBIO QUICK-TELL MONOCLONAL INDIRECT	1984-09-21
PMN K832867 STANBIO LABORATORY	FERTITUBE PREGNANCY TEST #1120	1984-02-03
PMN K832640 STANBIO LABORATORY	QUICK-TELL INDIRECT PREGNANCY TEST	1983-10-04
PMN K832557 STANBIO LABORATORY	FERTITELL DIRECT PREGNANCY TEST #1100	1983-09-12
PMN K832444 STANBIO LABORATORY	ENZYMATIC TRIGLYCERIDES #2000	1983-08-31
PMN K832159 STANBIO LABORATORY	UNITIZED ENZYMATIC GLUCOSE TEST SET	1983-08-16
PMN K831864 STANBIO LABORATORY	URIC-ACID TEST ENZYMATIC COLORIMETRIC	1983-07-22
PMN K831863 STANBIO LABORATORY	CHOLESTEROL-ENZYMATIC REAGENT SET	1983-07-22
PMN K831858 STANBIO LABORATORY	TRIGLYCERIDES REAGENT SET	1983-07-22
PMN K823237 STANBIO LABORATORY	BARBITURATE TEST SET #0550-050	1982-11-29
PMN K813349 STANBIO LABORATORY	BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL	1981-12-22
PMN K810055 STANBIO LABORATORY	STANBIO BILIRUBIN TEST SET	1981-02-02
PMN K801014 STANBIO LABORATORY	STANBIO ACETAMINOPHEN TEST SET #0850	1980-06-20
PMN K800693 STANBIO LABORATORY	STANBIO PROSTATIC ACID PHOSPHATASE TEST	1980-04-16
PMN K800190 STANBIO LABORATORY	STANBIO DIRECT URIC ACID TEST SET #0770	1980-02-13
PMN K781865 STANBIO LABORATORY	IRON BINDING CAPICITY MODEL 0370	1978-12-04
PMN K781635 STANBIO LABORATORY	CHLORIDE TEST SET, CAT.# 0210	1978-10-03
PMN K780545 STANBIO LABORATORY	SR-PLUS DIRECT CHOLESTEROL TEST	1978-05-26
PMN K780110 STANBIO LABORATORY	CSF TOTAL PROTEIN TEST SET #0340	1978-03-03
PMN K772257 STANBIO LABORATORY	ALKALINE PHOSPHATASE TEST SET	1977-12-22
PMN K771856 STANBIO LABORATORY	DIR. QUANT. COLOR. DETERM. SERUM CREAT.	1977-11-03