Single (Specified) Analyte Controls (Assayed And Unassayed)
FDA product code JJX · 460 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
- 1976-10-29 – 2017-04-04
JJX
1989-06-09
JJX
1989-05-22
DRI-DYE CHECK STRIPS (TM)-405
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JJX
1988-10-03
QTEST PREGNANCY TEST CONTROL
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JJX
1988-09-22
QUIDEL PREGNANCY TEST CONTROL
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JJX
1988-07-08
LIQUI-SERA SERUM ALCOHOL CONTROLS
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JJX
1988-02-24
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665
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JJX
1987-10-20
BILE ACIDS CONTROLS
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JJX
1987-09-21
TRI-LEVEL LIGAND CONTROL
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JJX
1987-09-16
REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL
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JJX
1987-03-12
TOTAL/IGE THEOPHYLLINE CONTROL SERA
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JJX
1986-11-05
HCG CONTROL KIT
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JJX
1986-09-15
TESTPACK ACUTE HCG SERUM CONTROLS
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JJX
1986-04-24
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
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JJX
1986-02-19
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
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JJX
1986-01-17
ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL
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JJX
1985-09-16
DIASCAN CONTROL
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JJX
1985-04-29
SUGAR-CHEX II
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JJX
1985-04-29
SUGAR-CHEX
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JJX
1985-04-10
BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3
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JJX
1984-09-28
PRECISET AMMONIA
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JJX
1984-01-13
TRI-LEVEL BILIRUBIN CONTROLS
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JJX
1984-01-11
CHEM TRAK LIQUID BILIRUBIN CONTROL
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JJX
1983-07-19
BETA SCAN NORMAL CONTROL SOLUTION
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JJX
1983-07-18
SPINAL FLUID TOTAL PROTEIN CONTROL
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JJX
1983-04-18
PROTOPORPHYRIN ZN CONTROL
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JJX
1983-04-05
PHADEBAS HUMYLASE CONTROL(H)
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JJX
1983-02-18
DAC-CEL DIAGNATAL HCG STANDARDS RD49
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JJX
1983-01-07
BIO INTERFERENCE BLANKING MATERIAL
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JJX
1983-01-07
ESTROCEPT STABILIZED ESTROGEN RECEPTOR
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JJX
1982-12-28
HUMAN PLASMA CONTROL FOR CEA-ROCHE
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JJX
1982-12-14
CARCINO-CEK
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JJX
1982-11-05
PHADEBASE HUMYLASE CONTROL
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JJX
1982-09-30
GLUCOSCAN CONTROLS
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JJX
1982-07-02
POSITIVE & NEGATIVE HCG URINE CONTROLS
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JJX
1982-07-02
LEVEL II CONTROL SERUM
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JJX
1982-05-12
FETAL-TEK CONTROL (IMMATURE/BORDERLINE)
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JJX
1981-10-06
C-PEPTIDE CONTROL PACK
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JJX
1981-07-23
HELENA VMA-SMC CONTROL
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JJX
1981-07-15
PRECINORM U & PRECIPATH U HUMAN SERUM
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JJX
1981-05-15
URINE PREGNANCY TEST STANDARD/CONTR. PK
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JJX
1980-12-22
HDL-CHOLESTEROL CONTROL SERUM
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JJX
1980-10-10
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO
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JJX
1980-09-16
SPINAL FLUID CONTROL(HUMAN)
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JJX
1980-04-16
CODE QAS.105 PROLACTIN CONTROL SERA
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JJX
1980-01-21
PENTEX LIPOPROTEIN CHOLESTEROL SOLU.
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JJX
1980-01-16
CK-MB (CREATINE KINASE-MB) RIA CONTROL
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JJX
1979-10-11
SERACON -LO DO26
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JJX
1979-08-10
BILIRUBIN CALIBRATOR CONTROL
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JJX
1979-07-17
ABNORMAL PROTEIN ELECTROPHORESIS CONTROL
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JJX
1979-07-17
NORMAL PROTEIN ELECTROPHORESIS CONTROL
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JJX
1979-04-04
DUPONT ACA CKMB VERIFIERS
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JJX
1979-03-21
SERUM PAK, HCG CONTROL
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JJX
1979-02-15
SERACON-LP
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JJX
1979-02-08
SERACON-HDL
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JJX
1978-01-06
ACA LIPASE VERIFIERS
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JJX
1977-10-28
ACA BILIRUBIN CALIBRATOR
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JJX
1977-10-13
EMIT THYROXINE CONTROL
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JJX
1977-07-11
SHAVE PREP SET
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JJX
1976-11-05
KETOTROL-E
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JJX
1976-10-29
LIPID CONTROL
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