Manual Antimicrobial Susceptibility Test Systems
FDA product code JWY · 426 cleared devices
Class 2
Microbiology
- Regulation
- 21 CFR 866.1640
- Review panel
- MI
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1981-02-10 – 2026-04-21
JWY
2008-07-24
JWY
2008-03-20
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
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JWY
2008-03-13
SENSITITRE 18-24 SUSCEPTIBILITY PLATE
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JWY
2008-01-22
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
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JWY
2006-12-20
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES
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JWY
2006-11-09
MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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JWY
2006-11-01
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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JWY
2006-10-26
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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JWY
2006-10-20
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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JWY
2006-10-13
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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JWY
2006-09-11
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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JWY
2006-08-31
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
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JWY
2006-07-21
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
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JWY
2006-07-18
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
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JWY
2006-05-16
SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL
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JWY
2006-04-21
SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-
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JWY
2005-10-13
ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA
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JWY
2005-09-21
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
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JWY
2005-06-23
DRIED GRAM-POSITIVE MIC/COMBO PANELS
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JWY
2005-02-14
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM
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JWY
2004-12-13
DAPTOMYCIN
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JWY
2004-11-19
ETEST FOR GEMIFLOXACIN
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JWY
2004-10-07
PASCO MIC AND MIC/ID PANELS
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JWY
2004-08-03
PASCO MIC AND MIC/ID PANELS
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JWY
2004-07-27
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL
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JWY
2004-06-07
PASCO MIC AND MIC/ID PANELS
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JWY
2004-04-26
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
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JWY
2004-04-07
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
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JWY
2004-02-10
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
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JWY
2004-02-03
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
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JWY
2003-11-18
PASCO MIC AND MIC/ID PANELS
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JWY
2003-09-15
PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)
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JWY
2003-08-29
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
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JWY
2003-08-19
PASCO MIC AND MIC/ID PANELS
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JWY
2003-07-30
PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN
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JWY
2003-07-16
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE
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JWY
2003-06-13
PASCO MIC AND MIC/ID PANELS
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JWY
2003-06-12
PASCO MIC AND MIC/ID PANELS (ERTAPENEM)
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JWY
2003-05-01
PASCO MIC AND MIC/ID PANELS
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JWY
2002-10-23
MICROSCAN SYNERGIES PLUS
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JWY
2002-10-08
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
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JWY
2002-09-25
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
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JWY
2002-09-25
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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JWY
2002-06-20
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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JWY
2002-06-17
MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
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JWY
2002-06-11
MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
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JWY
2002-06-06
ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
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JWY
2002-06-06
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME
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JWY
2002-06-06
MICROSTREP PLUS PANEL, AZITHROMYCIN
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JWY
2002-06-06
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE
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JWY
2002-06-03
MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM
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JWY
2002-05-15
CEFOTAXIME
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JWY
2002-05-09
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
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JWY
2002-05-09
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME
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JWY
2002-05-09
GATIFLOXIN
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JWY
2002-05-08
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN
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JWY
2002-05-06
MICROSTREP PLUS PANEL WITH AMPICILLIN
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JWY
2002-05-06
MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID
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JWY
2002-04-30
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR
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JWY
2002-04-30
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE
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JWY
2002-04-29
ETEST ERTAPENEM
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JWY
2002-04-26
MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
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JWY
2002-03-26
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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JWY
2002-03-22
DRIED GRAM NEGATIVE MIC/COMBO PANELS
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JWY
2002-03-20
PASCO MIC AND MIC/ID PANELS
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JWY
2002-03-14
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN
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JWY
2002-02-19
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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JWY
2001-12-21
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES
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JWY
2001-12-12
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE
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JWY
2001-12-12
MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS
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JWY
2001-11-26
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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JWY
2001-11-02
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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JWY
2001-10-30
HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
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JWY
2001-09-12
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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JWY
2001-08-29
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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JWY
2001-08-15
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
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JWY
2001-04-09
ETEST MEROPENEM
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JWY
2001-03-06
SUSCEPTIBILITY TEST PANEL
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JWY
2001-02-27
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
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JWY
2001-02-23
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
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JWY
2000-08-10
PASCO MIC AND MIC/ID PANELS
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JWY
2000-08-09
MODIFICATION TO PASCO MIC AND MIC/ID PANELS
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JWY
2000-08-07
ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP
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JWY
2000-07-24
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)
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JWY
2000-07-18
PASCO MIC AND MIC/ID PANELS
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JWY
2000-07-18
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
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JWY
2000-07-12
PASCO MIC AND MIC/ID PANELS
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JWY
2000-06-06
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)
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JWY
2000-05-23
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)
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JWY
2000-05-22
ETEST GATIFLOXACIN
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JWY
2000-05-18
ETEST MOXIFLOXACIN
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JWY
2000-02-18
MICROSTREP PLUS PANEL, LEVOFLOXACIN
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JWY
2000-01-14
MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN
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JWY
2000-01-14
MICROSTREP PLUS PANEL, VANCOMYCIN
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JWY
1999-12-09
MICROSTREP PLUS PANEL
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JWY
1999-09-21
PASCO MIC AND MIC/ID PANELS, VANCOMYCIN
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JWY
1999-09-16
MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN)
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JWY
1999-09-03
PASCO MIC AND MIC/ID PANELS (CEFEPIME)
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JWY
1999-08-30
PASCO MIC AND MIC/ID PANELS
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JWY
1999-08-26
PASCO MIC AND MIC/ID PANELS
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