Indicator, Biological Sterilization Process
FDA product code FRC · 190 cleared devices
Class 2
General Hospital
- Regulation
- 21 CFR 880.2800
- Review panel
- HO
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1977-01-21 – 2026-04-08
FRC
2009-10-21
FRC
2009-09-01
VERIFY SCBI 275F 3-10
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FRC
2009-04-29
MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292
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FRC
2009-03-16
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES
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FRC
2009-01-07
VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
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FRC
2008-05-28
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES
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FRC
2007-12-18
STERRAD 100NX TEST PACK
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FRC
2007-05-24
MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR
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FRC
2007-05-24
SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR
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FRC
2005-10-20
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR
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FRC
2005-08-19
STERRAD STERILIZER CYCLESURE TEST PACK
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FRC
2005-08-16
3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER
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FRC
2005-05-27
SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK
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FRC
2005-05-12
STERRAD NX CHALLENGE PACK
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FRC
2005-04-07
SPOR-TEST PA BIOLOGICAL INDICATOR KIT
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FRC
2005-03-23
MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS
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FRC
2004-09-13
RAVEN PROTEST - EO
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FRC
2004-08-09
RAVEN PROTEST - STEAM
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FRC
2004-05-25
MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS
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FRC
2004-05-06
MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
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FRC
2003-10-16
ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK
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FRC
2003-10-01
BIOSIGN STEAM-24 BIOLOGICAL INDICATOR
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FRC
2003-05-02
STERRAD CYCLESURE BIOLOGICAL INDICATOR
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FRC
2003-02-27
ALIBI BIOLOGICAL INDICATOR, MODEL WS
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FRC
2002-12-05
SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
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FRC
2002-10-25
SPSMEDICAL SPORVIEW STEAM BI TEST PACK
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FRC
2002-06-24
CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT
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FRC
2002-03-25
3M ATTEST 290 AUTO-READER
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FRC
2002-02-13
STERRAD CYCLESURE BIOLOGICAL INDICATOR
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FRC
2002-01-30
RAVEN BACTERIAL SPORE STRIPS
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FRC
2001-03-30
PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR
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FRC
2001-01-24
BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR
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FRC
2000-06-01
STERRAD BI TEST PACK
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FRC
1999-06-15
MODIFICATION OF: STERRAD BI TEST PACK
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FRC
1998-10-29
STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS
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FRC
1998-01-09
BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)
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FRC
1997-05-22
PROSPORE II
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FRC
1997-05-20
PROSPORE
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FRC
1997-03-04
EZTEST-GAS
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FRC
1997-02-25
EZTEST
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FRC
1996-09-18
PROSPORE(STEARO FOR STEAM STERILIZER)
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FRC
1996-08-23
STERITEC DISPOSABLE BIOLOGICAL TEST PACK
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FRC
1996-08-16
PROSPORE II
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FRC
1996-05-23
MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR
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FRC
1995-03-31
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X
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FRC
1994-12-22
ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR
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FRC
1994-04-04
EZTEST-STEAM
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FRC
1994-02-01
ATI(R) DISP BIOLOGICAL-PLUS TEST PACK
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FRC
1994-02-01
ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK
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FRC
1993-10-01
STERRAD BI TEST PACK
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FRC
1992-08-10
MDT CASTLE BIOSIGN TEST PACK
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FRC
1992-04-02
SPORE STRIP
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FRC
1992-03-27
SPORVIEW
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FRC
1991-03-08
EVIDENCE BIOLOGICAL INDICATOR
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FRC
1990-09-12
BI-O.K. STEAM TEST-PAK
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FRC
1990-07-19
ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER
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FRC
1990-07-03
ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR
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FRC
1990-03-08
ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE
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FRC
1990-02-09
BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR
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FRC
1989-11-17
SPORVIEW CULTURE MEDIA
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FRC
1989-09-11
STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.
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FRC
1989-09-11
STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE
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FRC
1989-03-29
BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.)
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FRC
1989-01-19
ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK
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FRC
1989-01-10
ATI-PYMAH DISPOSABLE BIOLOGICAL TEST PACK
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FRC
1988-07-06
BIOSIGN
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FRC
1986-12-17
ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.
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FRC
1986-07-17
ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR
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FRC
1986-06-18
ATI DISPOSABLE BIOLOGICAL TEST PACK
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FRC
1986-05-27
ASSERT EO BIOLOGICAL TEST PACK
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FRC
1986-05-20
SURGICOT STEAM TEST PACK
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FRC
1985-11-25
CHEMSPOR
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FRC
1985-11-01
DISPOSABLE STEAM BIOLOGICAL TEST PACK
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FRC
1985-06-17
BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH
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FRC
1984-10-02
48 HOUR BIOLOGICAL INDICATORS SPORSTRIP
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FRC
1984-05-25
SPORSTRIP
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FRC
1983-11-21
TRAVASPORE BIOLOGICAL INDICATOR
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FRC
1982-07-22
BACILLU S SUBTILIS BIOLOGICAL INDICA.
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FRC
1981-09-08
CASTLE TEC-TEST BIOLOGICAL INDICATOR
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FRC
1981-06-16
BACILLUM PUMILUS SPORE STRIPS
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FRC
1980-12-09
BIOLOGICAL INDICATOR - KEMMED & BIOSURE
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FRC
1980-08-13
SPOR-TEST-STRIP
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FRC
1980-04-16
STEAROTHERMOHILUS SPORE STRIPS
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FRC
1980-03-12
SURGICOT 2 INDICATOR SYSTEM
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FRC
1980-02-06
UNILAB CULTURING SET
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FRC
1980-01-29
UNISPORE-BIOLOGICAL INDICATORS
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FRC
1977-07-14
KENWOOD BIOLOGICAL STEOILIZ. INDICATOR
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FRC
1977-07-14
STEAM STERILIZATION INDICATOR
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FRC
1977-07-14
MONITOR, AERATION, TEC-TEST
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FRC
1977-01-21
MARKET CASTLE UNISPHERE
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