JSH · Culture Media, Non-Selective And Differential
Microbiology · 21 CFR 866.2320 · Class 1
Overview
| Product Code | JSH |
|---|---|
| Device Name | Culture Media, Non-Selective And Differential |
| Regulation | 21 CFR 866.2320 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A differential culture medium is a device that consists primarily of liquid biological materials intended for medical purposes to cultivate and identify different types of pathogenic microorganisms. The identification of these microorganisms is accomplished by the addition of a specific biochemical component(s) to the medium. Microorganisms are identified by a visible change (e.g., a color change) in a specific biochemical component(s) which indicates that specific metabolic reactions have occurred. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Cleared Devices (146)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K881560 | UREA BROTH | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881559 | UREA AGAR BASE | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881553 | RUSSELL DOUBLE SUGAR AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881551 | PHENOL RED BROTH BASE | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881540 | FLO AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881486 | DNASE TEST AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K880121 | MOELLERS DECARBOXYLASE, BASE | Hardy Media | Mar 31, 1988 | SESE |
| K880117 | OF MEDIUM BASE | Hardy Media | Mar 30, 1988 | SESE |
| K873270 | ACTINOMYCETE DIFFERENTIAL MEDIA | Central Media | Nov 4, 1987 | SESE |
| K873263 | MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA | Central Media | Oct 28, 1987 | SESE |
| K873411 | SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084 | Lakewood Biochemical Co., Inc. | Oct 6, 1987 | SESE |
| K873704 | MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053 | Lakewood Biochemical Co., Inc. | Oct 2, 1987 | SESE |
| K873703 | LYSINE IRON AGAR (LIA) PRODUCT #T3046 | Lakewood Biochemical Co., Inc. | Oct 2, 1987 | SESE |
| K872670 | IAFP MAC CONKEY AGAR | I.A.F. Production, Inc. | Aug 11, 1987 | SESE |
| K872020 | MUCATE AGAR, SLANTS AND MUCATE BROTH | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 2, 1987 | SESE |
| K871855 | SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM | Gibco Laboratories Life Technologies, Inc. | May 26, 1987 | SESE |
| K871701 | ARYLSULFATASE BROTH | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 20, 1987 | SESE |
| K870651 | BIGGY AGAR | Hardy Media | Apr 14, 1987 | SESE |
| K870636 | HEMOPHILUS ID QUAD PLATE | Hardy Media | Apr 14, 1987 | SESE |
| K871095 | CLED AGAR | bioMerieux, Inc. | Apr 3, 1987 | SESE |
| K864239 | CLED AGAR WITH ANDRADES INDICATOR | Mds Laboratories, Inc. | Mar 31, 1987 | SESE |
| K864454 | THERMOSTABLE NUCLEASE TEST AGAR | Dimed, Intl. | Nov 28, 1986 | SESE |
| K864205 | THERMONUCLEASE AGAR W/TOLUIDINE BLUE | Remel Co. | Nov 24, 1986 | SESE |
| K864100 | TRYCOPHYTON AGARS | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 31, 1986 | SESE |
| K863600 | MOTILITY INDOLE LYSINE SULFIDE (MILS) MEDIUM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 30, 1986 | SESE |
| K863599 | STARCH AGAR W/BROM CRESOL PURPLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 30, 1986 | SESE |
| K863573 | BIRD SEED AGAR | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 30, 1986 | SESE |
| K863572 | XANTHINE/TYROSINE/CASEIN AGAR | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 30, 1986 | SESE |
| K863523 | TOC (TWEEN 80 - OXGALL-CAFFEIC ACID) AGAR | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 19, 1986 | SESE |
| K862395 | BIOTIS DECARBOXYLASE MEDIA, BASE | Otisville Biotech, Inc. | Jul 3, 1986 | SESE |
| K862387 | BIOTIS HAEMOPHILUS IDENTIFICATION QUAD | Otisville Biotech, Inc. | Jul 3, 1986 | SESE |
| K860750 | PSEUDOMONAS AGAR P (MEDIUM A) | Gibco Laboratories Life Technologies, Inc. | Mar 10, 1986 | SESE |
| K853619 | APL TRIPLE SUGAR IRON AGAR | Apl Medical Supplies | Sep 16, 1985 | SESE |
| K853618 | APL SIM MEDIUM | Apl Medical Supplies | Sep 16, 1985 | SESE |
| K853610 | APL MOTILITY INDOLE ORNITHINE AGAR | Apl Medical Supplies | Sep 16, 1985 | SESE |
| K853616 | APL CHLAMYDOSPORE AGAR | Apl Medical Supplies | Sep 6, 1985 | SESE |
| K853615 | APL BILE ESCULIN/AZIDE AGAR | Apl Medical Supplies | Sep 6, 1985 | SESE |
| K853614 | APL FLUID THIOGLYCOLLATE MEDIUM | Apl Medical Supplies | Sep 6, 1985 | SESE |
| K853613 | APL GN BROTH | Apl Medical Supplies | Sep 6, 1985 | SESE |
| K853612 | APL DNASE TEST AGAR | Apl Medical Supplies | Sep 6, 1985 | SESE |
| K853336 | DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR | Hardy Media | Aug 29, 1985 | SESE |
| K852578 | CLED AGAR | American Laboratory Supply, Inc. | Jul 12, 1985 | SESE |
| K852064 | DRI-FORM PSEUDOMONAS AGAR F | Gibco Laboratories Life Technologies, Inc. | Jun 4, 1985 | SESE |
| K851597 | TRIPLE SUGAR IRON AGAR | Preferred Micro-Media | May 13, 1985 | SESE |
| K851596 | SIM MEDIUM | Preferred Micro-Media | May 13, 1985 | SESE |
| K851595 | SIMMONS CITRATE AGAR | Preferred Micro-Media | May 13, 1985 | SESE |
| K851576 | BIGGY AGAR NICKERSONS MEDIUM | Preferred Micro-Media | May 9, 1985 | SESE |
| K851602 | UREA AGAR | Preferred Micro-Media | May 8, 1985 | SESE |
| K851344 | OXIDATIVE FORMENTIVE MEDIUM | Micro Media Laboratories | Apr 22, 1985 | SESE |
| K851346 | PHENYLALANINE AGAR | Micro Media Laboratories | Apr 19, 1985 | SESE |
| K851345 | PURPLE BROTH | Micro Media Laboratories | Apr 19, 1985 | SESE |
| K851343 | BROM CRESOL PURPLE STARCH | Micro Media Laboratories | Apr 19, 1985 | SESE |
| K850721 | KLIGER'S IRON AGAR, SIM MEDIA, MRVP MEDIUM, BILE E | Rapid City Regional Hospital, Inc. | Mar 22, 1985 | SESE |
| K850719 | DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR | Rapid City Regional Hospital, Inc. | Mar 22, 1985 | SESE |
| K850844 | V AGAR | Micro Media Laboratories | Mar 20, 1985 | SESE |
| K850718 | CORN MEAL AGAR | Rapid City Regional Hospital, Inc. | Mar 20, 1985 | SESE |
| K844548 | UREA AGAR | bioMerieux, Inc. | Jan 16, 1985 | SESE |
| K844532 | SIMMONS CITRATE AGAR | bioMerieux, Inc. | Jan 7, 1985 | SESE |
| K844531 | TRIPLE SUGAR IRON | bioMerieux, Inc. | Jan 7, 1985 | SESE |
| K844522 | SF BROTH | bioMerieux, Inc. | Jan 7, 1985 | SESE |
| K844521 | SIM MEDIUM | bioMerieux, Inc. | Jan 7, 1985 | SESE |
| K844520 | KLIGER IRON AGAR | bioMerieux, Inc. | Jan 7, 1985 | SESE |
| K844519 | HAEMOPHILUS I.D. QUAD | bioMerieux, Inc. | Jan 7, 1985 | SESE |
| K844516 | STARCH HYDROLYSIS AGAR W/INDICATOR | bioMerieux, Inc. | Jan 7, 1985 | SESE |
| K844514 | DTM AGAR | bioMerieux, Inc. | Jan 7, 1985 | SESE |
| K844513 | V AGAR | bioMerieux, Inc. | Jan 7, 1985 | SESE |
| K843771 | BIOTIS SEVEN H 11 AGAR | Otisville Biotech, Inc. | Oct 10, 1984 | SESE |
| K843769 | BIOTIS LOWENSTEIN-JENSEN MEDIA | Otisville Biotech, Inc. | Oct 10, 1984 | SESE |
| K842850 | TRIPLE SUGAR IRON | Anarobe Systems | Aug 17, 1984 | SESE |
| K842851 | ORNITHINE INDOLE MOTILITY | Anarobe Systems | Aug 7, 1984 | SESE |
| K841843 | DIFFERENTIAL CULTURE MED. LEVINE EMB | Microline Scientific | May 31, 1984 | SESE |
| K841206 | NON-SELECTIVE & DIFFERENTIAL | Smith River Biologicals | Apr 17, 1984 | SESE |
| K840073 | ESCULIN AGAR PLATE | Otisville Biotech, Inc. | Feb 3, 1984 | SESE |
| K840071 | DNASE AGAR W/TOLUDINE BLUE PLATE | Otisville Biotech, Inc. | Feb 3, 1984 | SESE |
| K840070 | EGG YOLK AGAR PLATE | Otisville Biotech, Inc. | Jan 30, 1984 | SESE |
| K840068 | BILE ESCULIN AGAR PLATE | Otisville Biotech, Inc. | Jan 30, 1984 | SESE |
| K834509 | ACETAMIDE AGAR SLANTS | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 27, 1984 | SESE |
| K834205 | MIDDLEBROOK & COHN 7H10 AGAR BASE | Acumedia Manufacturers, Inc. | Jan 3, 1984 | SESE |
| K834204 | MIDDLEBROOK & COHN 7H11 AGAR BASE | Acumedia Manufacturers, Inc. | Jan 3, 1984 | SESE |
| K834009 | SIMMONS CITRATE AGAR | Micro Media Laboratories | Dec 22, 1983 | SESE |
| K833291 | JH PEPTONE AGAR | Acumedia Manufacturers, Inc. | Nov 28, 1983 | SESE |
| K833216 | MOTILITY TEST MEDIUM | Acumedia Manufacturers, Inc. | Oct 27, 1983 | SESE |
| K833213 | KLIGLER IRON AGAR | Acumedia Manufacturers, Inc. | Oct 27, 1983 | SESE |
| K833208 | MR-VP BROTH | Acumedia Manufacturers, Inc. | Oct 27, 1983 | SESE |
| K833206 | TECH AGAR | Acumedia Manufacturers, Inc. | Oct 27, 1983 | SESE |
| K833202 | MOELLER DECARBOXYLASE BROTH | Acumedia Manufacturers, Inc. | Oct 27, 1983 | SESE |
| K833201 | SIMMONS CITRATE AGAR | Acumedia Manufacturers, Inc. | Oct 27, 1983 | SESE |
| K832532 | AGAR PLATE XLD | Otisville Biotech, Inc. | Sep 29, 1983 | SESE |
| K832616 | MACCONKEY AGAR MEDIA | Carroll Biological Corp. | Sep 12, 1983 | SESE |
| K832574 | BTB LACTOSE AGAR | Acumedia Manufacturers, Inc. | Sep 12, 1983 | SESE |
| K832573 | C.L.E.D. MEDIUM | Acumedia Manufacturers, Inc. | Sep 12, 1983 | SESE |
| K831827 | EGG YOLK AGAR | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 26, 1983 | SESE |
| K830073 | LEVINE EMB AGAR | bioMerieux, Inc. | Feb 9, 1983 | SESE |
| K830020 | ACETAMIDE AGAR | Gibco Laboratories Life Technologies, Inc. | Feb 7, 1983 | SESE |
| K823311 | COLUMBIA V AGAR W/5% HUMAN BLOOD | Troy Biologicals, Inc. | Dec 15, 1982 | SESE |
| K823091 | H BROTH | Granite Diagnostics, Inc. | Nov 5, 1982 | SESE |
| K823071 | RICE EXTRACT AGAR | Granite Diagnostics, Inc. | Nov 5, 1982 | SESE |
| K823070 | ACETAMIDE AGAR SLANT | Granite Diagnostics, Inc. | Nov 5, 1982 | SESE |
| K822702 | V AGAR | Granite Diagnostics, Inc. | Sep 30, 1982 | SESE |
| K822377 | HAEMOPHILUS ID PLATE | Granite Diagnostics, Inc. | Aug 25, 1982 | SESE |
| K821659 | RESPIRACULT-STREP DEEP BED CULTURE PAD | Orion Diagnostica, Inc. | Aug 5, 1982 | SESE |
| K821595 | MOTILITY TEST MEDIUM | Hardy Media | Jul 8, 1982 | SESE |
| K821609 | VAGAR | Hardy Media | Jul 6, 1982 | SESE |
| K821425 | COLUMBIA BLOOD AGAR W/5% SHEEP BLOOD | Interstate Media | Jun 1, 1982 | SESE |
| K821424 | TRYPTIC SOY AGAR W/5% SHEEP BLOOD | Interstate Media | Jun 1, 1982 | SESE |
| K821418 | TRYPTOSE BLOOD AGAR W/5% SHEEP BLOOD | Interstate Media | Jun 1, 1982 | SESE |
| K821417 | TRYPTIC SOY AGAR W/10% SHEEP BLOOD | Interstate Media | Jun 1, 1982 | SESE |
| K821302 | #50003 QUAD DIAGNOSTIC SYSTEM | Biomedia, Inc. | Jun 1, 1982 | SESE |
| K811852 | REDUCT-ASE TUBES | Microchemical Specialities, Co. | Jul 16, 1981 | SESE |
| K811597 | UREA AGAR SLANT | Micro Media Laboratories | Jun 25, 1981 | SESE |
| K811335 | THIOGLYCOLLATE GELATIN MEDIUM | Acumedia Manufacturers, Inc. | May 29, 1981 | SESE |
| K811330 | SIM MEDIUM | Acumedia Manufacturers, Inc. | May 29, 1981 | SESE |
| K811130 | LACTOSE BROTH | Acumedia Manufacturers, Inc. | May 5, 1981 | SESE |
| K811044 | TRIPLE SUGAR IRON AGAR | Acumedia Manufacturers, Inc. | May 5, 1981 | SESE |
| K802995 | TRYPTICASE SOY AGAR W/5% SHEEP BLD. CELL | Sacks Farms Biological Products | Dec 22, 1980 | SESE |
| K802994 | TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL | Sacks Farms Biological Products | Dec 22, 1980 | SESE |
| K801817 | MICROBIOLOGY CULTURE MEDIA, C.L.E.D. | Radiation Technology, Inc. | Aug 27, 1980 | SESE |
| K801847 | TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA | Radiation Technology, Inc. | Aug 13, 1980 | SESE |
| K800978 | XYLOSE LYSINE DESOXYCHOLATE AGAR | Quality Assurance Laboratory, Inc. | May 28, 1980 | SESE |
| K800984 | EOSIN METHYLENE BLUE AGAR, LEVINE | Quality Assurance Laboratory, Inc. | May 23, 1980 | SESE |
| K800982 | SALMONELLA SHIGELLA AGAR | Quality Assurance Laboratory, Inc. | May 23, 1980 | SESE |
| K800818 | CHLAMYDOSPORE AGAR | Isle Media and Sterile Products, Inc. | Apr 24, 1980 | SESE |
| K792542 | VOGEL-JOHNSON AGAR | Isle Media and Sterile Products, Inc. | Dec 31, 1979 | SESE |
| K792421 | DECARBOXYLASE BROTH BASE WITH OR WITH- | Isle Media and Sterile Products, Inc. | Dec 31, 1979 | SESE |
| K792544 | LYSINE IRON AGAR | Isle Media and Sterile Products, Inc. | Dec 27, 1979 | SESE |
| K792288 | TRYPTONE BROTH (TRYPTOPHANE BROTH) | Isle Media and Sterile Products, Inc. | Dec 19, 1979 | SESE |
| K792286 | MR-VP MEDIUM | Isle Media and Sterile Products, Inc. | Dec 19, 1979 | SESE |
| K791946 | OF BASAL MEDIUM | Isle Media and Sterile Products, Inc. | Oct 30, 1979 | SESE |
| K791944 | NITRATE AGAR | Isle Media and Sterile Products, Inc. | Oct 30, 1979 | SESE |
| K791941 | PHENOL RED BROTH | Isle Media and Sterile Products, Inc. | Oct 30, 1979 | SESE |
| K791939 | PHENOL RED AGAR | Isle Media and Sterile Products, Inc. | Oct 30, 1979 | SESE |
| K791817 | MIO MEDIUM (MOTILITY INDOLE ORNITHINE) | Isle Media and Sterile Products, Inc. | Oct 1, 1979 | SESE |
| K791814 | BILE ESCULIN AGAR | Isle Media and Sterile Products, Inc. | Oct 1, 1979 | SESE |
| K791813 | DNASE TEST AGAR W/METHYL GREEN | Isle Media and Sterile Products, Inc. | Oct 1, 1979 | SESE |
| K791671 | DNASE TEST AGAR | Isle Media and Sterile Products, Inc. | Oct 1, 1979 | SESE |
| K791594 | CYSTINE TRYPTIC AGAR | Isle Media and Sterile Products, Inc. | Sep 17, 1979 | SESE |
| K791591 | MOTILITY TEST MEDIUM | Isle Media and Sterile Products, Inc. | Sep 17, 1979 | SESE |
| K791590 | PHENYLALANINE AGAR | Isle Media and Sterile Products, Inc. | Sep 17, 1979 | SESE |
| K791556 | MACCONKEY AGAR (PLATE) | American Laboratory Supply, Inc. | Sep 17, 1979 | SESE |
| K790627 | LOMBARD-DOWELL DEOXYRILBONUCLERIC ACID | Anaerobe Systems | May 1, 1979 | SESE |
| K790623 | LOMBARD-DOWELL MILK AGAR | Anaerobe Systems | Apr 23, 1979 | SESE |
| K790618 | LOMBARD-DOWELL STARCH AGAR | Anaerobe Systems | Apr 23, 1979 | SESE |
| K790229 | VAGINALIS, HAEMOPHILUS | Los Angeles Biological Products | Feb 26, 1979 | SESE |
| K780615 | BLOOD CULTURE MEDIA | Meda Stat Diagnostics, Inc. | May 4, 1978 | SESE |
| K771936 | MICROBIOLOGICAL CULTURE MEDIUM | Scott Laboratories, Inc. | Dec 6, 1977 | SESE |
| K771686 | UREAPLASMA DIFFERENTIAL BASAL AGAR MED. | Gibco Laboratories Life Technologies, Inc. | Oct 28, 1977 | SESE |
Top Applicants
- Acumedia Manufacturers, Inc. — 21 clearances
- Isle Media and Sterile Products, Inc. — 17 clearances
- bioMerieux, Inc. — 12 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 10 clearances
- Otisville Biotech, Inc. — 9 clearances
