Discs, Strips And Reagents, Microorganism Differentiation
FDA product code JTO · 244 cleared devices
Class 1
Microbiology
- Regulation
- 21 CFR 866.2660
- Review panel
- MI
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-12-09 – 2005-09-01
JTO
2005-09-01
JTO
1997-04-24
PYR SWAB
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JTO
1997-04-17
GRAM SWAB
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JTO
1997-04-02
INDOLE SWAB
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JTO
1997-02-06
LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
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JTO
1996-10-08
IDS RAPID CB PLUS SYSTEM
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JTO
1996-06-17
COLISCREEN
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JTO
1996-04-18
M. CAT BUTYRATE DISK
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JTO
1996-02-29
GIBSON ID-M. CAT.
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JTO
1996-02-06
DRYSLIDE CARTARRHALIS
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JTO
1995-12-20
LYFO(TM) DIFFERIENTAL DISK-PYR
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JTO
1995-11-20
GIBSON ID A.E. TEST
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JTO
1995-08-24
LYFO(TM) DIFFERENTIAL DISK
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JTO
1995-05-05
B-L RED(TM) DISCS
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JTO
1995-04-24
LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN
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JTO
1995-04-24
LYFO(TM) DIFFERENTIAL DISK-BILE
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JTO
1995-04-24
LYFO(TM) DIFFERENTIAL DISK-STERILE DISK
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JTO
1995-04-24
LYFO(TM) DIFFERENTIAL DISK-SPS
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JTO
1994-09-14
SWABZYME OXIDASE
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JTO
1994-09-09
GONOCHEK II REAGENT TUBES
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JTO
1994-09-09
B-LACTAMASE REAGENT TUBES
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JTO
1994-09-09
GONOCHEK-II, MODIFICATION
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JTO
1994-08-26
EY-20 REAGENT TUBES
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JTO
1994-08-26
STREP-A-CHEK(TM) REAGENT STRIPS
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JTO
1994-08-26
STREP-A-CHEK
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JTO
1994-08-02
STREP-SURE A/E
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JTO
1994-06-30
DISPENS-O-DISC(TM) NITROCEFIN
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JTO
1994-05-20
BACTICARD STREP
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JTO
1994-04-21
SERIM PYLORITEK REAGENT STRIPS
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JTO
1994-02-23
BACTICARD E. COLI
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JTO
1993-12-15
PYR TEST KIT
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JTO
1993-11-05
VISI-SPOT
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JTO
1993-10-28
BACTICARD STREP
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JTO
1993-06-15
NINHYDRIN REAGENT
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JTO
1993-05-12
CATALASE REAGENT
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JTO
1993-05-12
OXYSTRIP
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JTO
1993-05-11
FERRIC CHLORID REAGENT, 10%
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JTO
1993-05-11
BACTIDROP(TM) MUCAP
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JTO
1993-04-23
VOGUES-PROSKAUER REAGENT A & B
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JTO
1993-04-23
INDOLE SPOT & INDOLE KOVACS REAGENT
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JTO
1993-04-23
NITRATE REAGENTS A, B AND C
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JTO
1993-01-26
BBL NINHYDRIN REAGENT DROPPERS
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JTO
1993-01-26
BBL NITRATE A, B REAGENT DROPPERS
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JTO
1993-01-26
BBL PYR REAGENT DROPPERS
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JTO
1993-01-15
DRYSLIDE(TM) INDOLE
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JTO
1992-10-05
INDOXYL ACETATE DISK
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JTO
1992-09-28
LAP DISK
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JTO
1992-06-19
DRYSLIDE(TM), PYR
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JTO
1992-06-19
BACTIDROP INDOLE (ERLICH'S)
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JTO
1992-05-22
BACTIDROP PYR
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JTO
1992-05-22
BACTIDROP NINHYDRIN
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JTO
1992-04-22
NIACIN CONTROL DISKS
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JTO
1991-09-23
BACTIDROP(TM) OXIDASE
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JTO
1991-09-23
BACTIDROP(TM) VOGES-PROSKAUER B
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JTO
1991-09-23
BACTIDROP(TM) DOBELL & O'CONNOR IODINE
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JTO
1991-09-23
BACTIDROP(TM) VOGES-PROSKAUER A
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JTO
1991-09-23
BACTIDROP(TM) FERRIC CHLORIDE (10%)
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JTO
1991-09-19
BACTIDROP(TM) NITRATE A
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JTO
1991-09-19
BACTIDROP (TM) NITRATE B
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JTO
1991-09-18
BACTIDROP(TM) INDOLE (KOVACS)
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JTO
1991-09-18
BACTIDROP(TM) SPOT INDOLE
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JTO
1991-09-18
BACTIDROP(TM) DESOXYCHOLATE (10%)
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JTO
1991-08-23
BBL(R) DMACA INDOLE REAGENT DROPPERS
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JTO
1991-02-27
LAP DISCS
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JTO
1991-02-26
M. CAT. BUTYRATE DISC
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JTO
1991-02-20
NITRATE DISK
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JTO
1991-01-25
VANCOMYCIN DISK-5 MCG
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JTO
1990-10-02
CATARRHALIS TEST STRIP
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JTO
1990-07-16
DMAC INDOLE REAGENT
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JTO
1990-06-20
DRYSLIDE, BETA-LACTAMASE
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JTO
1990-06-01
PATHODX PYR KIT
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JTO
1990-04-16
DMAC INDOLE REAGENT
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JTO
1989-12-18
DIFCO OXIDASE DRYSLIDE
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JTO
1989-09-28
ROSCO PYRR
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JTO
1989-02-17
JAMES REAGENT
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JTO
1989-02-16
ALN DISCS
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JTO
1989-02-16
PRO DISCS
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JTO
1988-06-16
B. CAT CONFIRM
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JTO
1988-04-01
PYR/ESCULIN DISK
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JTO
1988-01-05
MUG-INDOLE DISC
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JTO
1987-10-15
IDENTICULT-BL
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JTO
1987-08-19
CONTROLCHEK II(TM)
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JTO
1987-05-28
LD PRESUMPTO QUAD
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JTO
1987-04-29
CONTROLCHEK(TM)
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JTO
1987-04-21
CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION
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JTO
1987-04-21
GEN-PROBE BETA-LACTAMASE TEST KIT
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JTO
1987-04-21
CHROMAGEN TEST FOR GROUP D ENTEROCOCCUS
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JTO
1987-04-15
CHROMAGEN TEST FOR GROUP A STREP
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JTO
1987-04-03
SPOTTEST MICRODASE
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JTO
1987-04-03
SPOTTEST 10% SODIUM DESOXYCHOLATE
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JTO
1987-03-31
GARNERELLA VAGINALIS IDENTIFICATION KIT
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JTO
1987-02-26
SPOTTEST PYR REAGENT
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JTO
1986-09-30
ONPG SOLUTION
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JTO
1986-09-15
NEIS NZY
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JTO
1986-07-17
DISPENS-O-DISC DIFFERENTIATION DISKS PYR
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JTO
1986-06-03
D'ALA RAPID TEST
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JTO
1986-06-03
HIPPURATE HYDROLYSIS TEST
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JTO
1986-05-20
SENSITITRE AUTO ID PLATE, AP70
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JTO
1986-04-11
MACCONKEY W/MUG
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JTO
1986-03-11
DIFFERENTIATION DISKS KANAMYCIN 1000 MCG
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