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
1993-11-16
JWY
1993-11-16
PASCO MIC AND MIC/ID PANELS
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JWY
1993-08-18
PASCO MIC AND MIC/ID PANELS
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JWY
1993-07-20
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
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JWY
1993-06-25
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
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JWY
1993-05-18
BBL CRYSTAL MRSA ID SYSTEM
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JWY
1993-05-12
PASCO MIC AND MIC/ID PANELS
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JWY
1993-04-05
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
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JWY
1993-03-26
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
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JWY
1993-03-09
SENSITITRE SUSCEPTIBILITY PLATES
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JWY
1993-01-15
CATION ADJUSTED MUELLER HINTON BROTH
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JWY
1992-12-11
DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS
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JWY
1992-12-03
API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC
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JWY
1992-11-30
ANTIMICROBIAL SUSCEPTIBILITY TEST
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JWY
1992-10-13
API UNISCEPT KB/TYPE 2 AND 3
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JWY
1992-08-20
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
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JWY
1992-08-19
ANTIMICROBIAL SUSCETIBILITY TEST PANEL
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JWY
1992-07-28
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
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JWY
1992-02-18
HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
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JWY
1991-09-25
THE E TEST, MODIFICATION
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JWY
1991-09-06
API UNISCEPT KB
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JWY
1991-08-29
API UNISCEPT MIC/UNISCEPT MICRO-MIC
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JWY
1991-08-22
JUSTONE(TM)
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JWY
1991-08-22
GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)
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JWY
1991-05-15
ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN
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JWY
1991-05-08
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (CEFOTETAN
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JWY
1991-05-08
ANTIMICROBIAL SUSCEPT. TEST PANEL (CEFTIZOXIME)
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JWY
1991-05-08
ANTIMICROBIAL SUSCEPT. TEST PANEL(TRIMETHOPRIM)
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JWY
1991-05-08
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (IMIPENEM)
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JWY
1991-04-22
ANTIMICROBIAL SUSCEPT. TEST PANEL CEFONICID
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JWY
1991-04-22
ANTIMICROBIAL SUSCEPT. TEST PANEL TICARCILLIN
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JWY
1991-04-22
ANTIMICROBIAL SUSCEPT. TEST PANEL TICARC./CLAVUL.
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JWY
1991-04-22
ANITIMICROBIAL SUSCEPT. TEST PANEL AMOX./CLAVUL.
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JWY
1991-04-22
ANTIMICROBIAL GENTAMICIN
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JWY
1991-04-22
ANTIMICROBIAL TOBRAMYCIN
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JWY
1991-04-22
ANTIMICROBIAL AMPICILLIN
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JWY
1991-04-18
ANTIMICROBIAL AMIKACIN
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JWY
1991-04-17
ANTIMICROBIAL CEFUROXIME
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JWY
1991-04-17
ANTIMICROBIAL AMPICILLIN/SULBACTAM
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JWY
1991-03-11
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
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JWY
1991-03-05
EF SYNERGY QUAD MODIFIED
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JWY
1991-02-25
ANTIMICROBIAL CEFTRIAXONE
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JWY
1991-02-25
ANTIMICROBIAL CEFOPERAZONE
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JWY
1991-02-07
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
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JWY
1991-02-07
ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS
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JWY
1990-12-21
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED
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JWY
1990-11-13
EF SYNERGY QUAD
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JWY
1990-11-08
FASTIDIOUS MIC PANEL
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JWY
1990-07-16
PASCO MIC AND MIC/ID MODIFIED
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JWY
1990-03-07
SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN
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JWY
1990-02-09
MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE
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JWY
1990-02-05
SUPPLEMENT TO ANAEROBIC MIC PANEL
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JWY
1990-01-29
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
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JWY
1990-01-29
PASCO MIC/ID GRAM-POSITIVE PANEL
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JWY
1989-11-13
API UNISCEPT KB
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JWY
1989-11-06
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
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JWY
1989-10-10
SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID
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JWY
1989-09-05
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
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JWY
1989-08-15
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
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JWY
1989-03-27
ANAEROBIC MIC PANEL
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JWY
1988-11-22
MODIFICATION MICRO-MIC
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JWY
1988-11-22
MODIFICATION MIC/API UNISCEPT(R)
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JWY
1988-10-12
SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL
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JWY
1988-10-12
SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL
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JWY
1988-09-27
SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325
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JWY
1988-09-26
SCEPTOR RESISTANT GRAM-NEGATIVE MIC/ID #80332
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JWY
1988-09-26
SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL #80329
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JWY
1988-09-26
SCEPTOR RESISTANT GRAM-NEGATIVE MIC PANEL #80331
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JWY
1988-09-26
SCEPTOR PSEUDOMONAS PLUS MIC PANEL CAT.# 80328
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JWY
1988-09-26
SCEPTOR STAPHYLOCOCCUS MIC #80324
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JWY
1988-09-26
SCEPTOR STREPTOCOCCUS MIC PANEL #80322
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JWY
1988-09-26
SCEPTOR STREPTOCOCCUS MIC/ID PANEL #80323
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JWY
1988-09-08
ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL
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JWY
1988-09-07
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
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JWY
1988-09-07
GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS
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JWY
1988-08-29
SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN
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JWY
1988-08-17
SCEPTOR NEW ANTIMICROBIAL AGENT: IMIPENEM
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JWY
1988-08-17
SCEPTOR EXTEN. OF CONCENTRATION RANGE: PENCILLIN
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JWY
1988-08-17
SCEPTOR NEW ANTIMICROBIAL AGENT: AMPICILLIN/SULBAC
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JWY
1988-07-18
SCEPTOR GRAM-NEGATIVE URINE ISOLATE MIC/ID PANEL
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JWY
1988-07-14
SCEPTOR - NEW ANTIMICROBIAL AGENT: CEFACLOR
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JWY
1988-07-12
SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88)
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JWY
1988-07-12
SCEPTOR ENTERIC MIC PANEL (REVISED 4/88)
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JWY
1988-07-08
SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN
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JWY
1988-07-06
LABELING FOR REVISED PASCO MIC AND MIC/ID PANELS
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JWY
1988-05-13
SENSITITRE STABILITY PLATES
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JWY
1988-04-12
GRAM NEGATIVE MIC/COMBO PANELS
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JWY
1988-03-23
MODIFICATIONS TO API UNISCEPT (R) KB
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JWY
1988-03-16
ADDITION OF AMPICILLIN/SULBACTAM & CIPROFLOXACIN
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JWY
1988-02-18
PRECEPT(TM) CIPROFLOXACIN
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JWY
1988-01-11
GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL
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JWY
1987-12-09
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC
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JWY
1987-12-02
NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO
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JWY
1987-06-15
SENSIR SYSTEM
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JWY
1987-04-14
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
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JWY
1987-03-23
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT(R)MIC
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JWY
1987-02-20
API UNISCEPT (TM) KB
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JWY
1987-02-02
REVISED RESISTANT 5 MIC PANEL
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JWY
1987-02-02
MICRODILUTION MIC PANELS
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JWY
1986-12-18
MIC - CONCEPT(TM) RX-2
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