Multi-Analyte Controls, All Kinds (Assayed)
FDA product code JJY · 659 cleared devices
Class 1
Clinical Chemistry
- Regulation
- 21 CFR 862.1660
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-11-05 – 2017-03-31
JJY
1992-08-10
JJY
1992-07-10
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3
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JJY
1992-07-07
DADE URINE CHEMISTRY CONTROL LEVELS I AND II
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JJY
1992-06-19
KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024
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JJY
1992-06-09
LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2
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JJY
1992-05-07
KEMTROL SERUM CONTROL-ABNORMAL
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JJY
1992-04-17
AMERLITE FREE THYROID CONTROL SERA LAN.4002
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JJY
1992-04-07
HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL
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JJY
1992-03-23
CHEM-CHEM MULTI-ANALYTE (MODIFIED)
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JJY
1992-03-18
RIATRAC PLUS
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JJY
1992-03-17
TRI-POINT LIQUIMMUNE LIGAND CONTROL LEVELS 1,2,3
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JJY
1992-02-06
N/T PROTEIN CONTROL UY
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JJY
1992-01-09
LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2
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JJY
1991-12-18
RAI-TROL ELEVATED LIPIDS CONTROL
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JJY
1991-11-22
CVM
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JJY
1991-09-27
CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)
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JJY
1991-09-25
LIPID LINEARITY CONTROLS
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JJY
1991-09-19
CHEM-CHEX
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JJY
1991-09-06
ENZYME LINEARITY CONTROL
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JJY
1991-08-12
DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL
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JJY
1991-07-30
TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL
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JJY
1991-07-17
LINEARITY TEST KITS
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JJY
1991-06-13
ANEMIA I, II
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JJY
1991-06-10
DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL
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JJY
1991-05-22
CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE
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JJY
1991-05-15
HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED
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JJY
1991-05-10
DOCUMENT REFLECTANCE II LINEARITY TEST SET
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JJY
1991-05-01
ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III
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JJY
1991-05-01
ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I
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JJY
1991-01-23
CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II
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JJY
1990-12-26
CHEM-CHEX LIPID
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JJY
1990-12-18
CHOLESTECH L.D.X. LEVEL 1 CONTROL
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JJY
1990-12-18
CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL
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JJY
1990-12-07
HDL CHOLESTEROL CONTROL
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JJY
1990-12-07
LDL-DIRECT CONTROLS
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JJY
1990-12-06
QCLYTE PROTEIN BASED ISE CONTROL
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JJY
1990-12-06
ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL
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JJY
1990-12-06
CLINICAL CHEMISTRY CONTROL
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JJY
1990-11-09
KODATROL I AND II CONTROL AND DILUENT SET
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JJY
1990-11-01
TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III
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JJY
1990-10-26
URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS
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JJY
1990-10-12
HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)
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JJY
1990-10-04
DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2
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JJY
1990-09-24
DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III
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JJY
1990-09-07
AFFINITY HLH TEST SYSTEM
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JJY
1990-09-07
KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL
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JJY
1990-09-07
CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR
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JJY
1990-08-22
CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL
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JJY
1990-08-17
CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT
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JJY
1990-08-17
MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY
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JJY
1990-07-19
BILIRUBIN CONTROL
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JJY
1990-07-19
BLOOD GAS/ISE CONTROLS
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JJY
1990-07-17
HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND
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JJY
1990-07-17
LVM QUALITY CONTROL SERUM
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JJY
1990-07-10
PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM
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JJY
1990-07-10
PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM
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JJY
1990-06-12
BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS
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JJY
1990-05-31
DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET
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JJY
1990-05-01
LIG/TDM A, B, C
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JJY
1990-04-26
TECHNICON TESTPOINT(TM) LIGAND CONTROL
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JJY
1990-04-19
MULTICONSTITUENT SERUM RANGE LINEARITY #88234
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JJY
1990-04-16
CHEM-CHEX
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JJY
1990-02-02
DADE(R) TDM CONTROL
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JJY
1990-01-19
CLP NORMAL LIPID CONTROL
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JJY
1990-01-18
LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3
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JJY
1990-01-10
CLP COMPREHENSIVE LIPID CONTROL-HR
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JJY
1990-01-10
CLP COMPREHENSIVE LIPID CONTROL-LR
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JJY
1990-01-02
DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY
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JJY
1989-12-27
NORMAL AND ABNORMAL CONTROL SERA
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JJY
1989-09-28
SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS
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JJY
1989-08-11
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II
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JJY
1989-08-01
LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM
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JJY
1989-07-20
DADE LIPID-TROL
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JJY
1989-06-23
DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET
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JJY
1989-06-23
DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET
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JJY
1989-06-13
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II
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JJY
1989-05-09
MONI-TROL(R)
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JJY
1989-03-20
AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)
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JJY
1989-03-15
RIATRAC PLUS
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JJY
1989-03-15
RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109)
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JJY
1989-03-09
KENLOR HUMAN SPINAL FLUID CONTROL LIQUID
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JJY
1989-03-08
SHAPE-ACTIO URINALYSIS CONTROLS
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JJY
1989-01-27
GAS TRAK PLUS
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JJY
1988-11-10
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL
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JJY
1988-10-25
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II
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JJY
1988-10-13
DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST
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JJY
1988-10-11
AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA
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JJY
1988-10-06
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL
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JJY
1988-10-06
AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190
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JJY
1988-09-30
AMERLITE FREE THYROID CONTROL SERA LAN.4002
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JJY
1988-09-13
LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL
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JJY
1988-09-09
A.QC CHEMISTRY CONTROL LEVEL 2
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JJY
1988-08-08
AMERLITE TOTAL THYROID CONTROL SERA LAN.4001
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JJY
1988-07-21
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
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JJY
1988-07-08
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
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JJY
1988-07-06
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN
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JJY
1988-07-06
CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS
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JJY
1988-07-01
CLP LIPOPROTEIN ELECTROPHORESIS CONTROL
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JJY
1988-06-02
SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS
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JJY
1988-05-27
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693
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