Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Culture Media, Enriched

FDA product code KZI · 51 cleared devices

Class 1 Microbiology

Regulation: 21 CFR 866.2330
Review panel: MI
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1982-03-16 – 1988-10-25

KZI 1988-10-25

LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)

Applicant Oxoid U.S.A., Inc.

K number K884208

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KZI 1988-06-02

DIAMOND'S MEDIUM MODIFIED

Applicant Remel Co.

K number K881995

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KZI 1988-03-31

MIDDLEBROOK 7H11 AGAR

Applicant Hardy Media

K number K880134

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KZI 1988-03-31

LOWENSTEIN-JENSEN, GRUFT

Applicant Hardy Media

K number K880131

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KZI 1988-03-31

MIDDLEBROOK 7H9 BROTH

Applicant Hardy Media

K number K880122

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KZI 1988-03-30

WALLENSTEIN MEDIUM SLANT

Applicant Hardy Media

K number K880138

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KZI 1988-03-30

CYSTINE TRYPTIC MEDIUM BASE

Applicant Hardy Media

K number K880109

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KZI 1988-03-07

POTATO DEXTROSE AGAR

Applicant Hardy Media

K number K880127

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KZI 1988-01-28

BIOTIS (TM) SABHI (DOUBLE POUR)

Applicant Otisville Biopharm, Inc.

K number K874179

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KZI 1987-12-04

BIOTIS (TM) BCYE

Applicant Otisville Biopharm, Inc.

K number K874177

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KZI 1987-11-04

ECG BASED MEDIA

Applicant Central Media

K number K873267

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KZI 1987-10-28

MIDDLEBROOK BASED MEDIA

Applicant Central Media

K number K873266

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KZI 1987-10-23

MICRO CULTURE MEDIA P3141, P3136, P3148, P3748

Applicant Lakewood Biochemical Co., Inc.

K number K873952

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KZI 1987-09-29

SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300

Applicant Lakewood Biochemical Co., Inc.

K number K873321

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KZI 1987-09-29

SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD

Applicant Lakewood Biochemical Co., Inc.

K number K873320

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KZI 1987-08-24

TRYPTIC SOY AGAR W/5% SHEEP BLOOD - #T1405

Applicant Lakewood Biochemical Co., Inc.

K number K873061

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KZI 1987-08-24

TRYPTIC SOY AGAR W/5% SHEEP BLOOD - PRODUCT P1002

Applicant Lakewood Biochemical Co., Inc.

K number K873060

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KZI 1987-08-24

TRYPTIC SOY AGAR (TSA) W/5% HORSE BLOOD #P2810

Applicant Lakewood Biochemical Co., Inc.

K number K873058

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KZI 1987-08-11

IAFP LOWENSTEIN JENSEN SLANT

Applicant I.A.F. Production, Inc.

K number K872685

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KZI 1987-08-07

IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1

Applicant I.A.F. Production, Inc.

K number K872678

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KZI 1987-08-07

IAFP T.S.A. W/5% SHEEP BLOOD

Applicant I.A.F. Production, Inc.

K number K872671

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KZI 1987-06-22

FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K872193

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KZI 1987-04-14

MIDDLEBROOK 7H10 AGAR

Applicant Hardy Media

K number K870646

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KZI 1987-04-14

COOKED MEAT MEDIUM WITH IRON

Applicant Hardy Media

K number K870642

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KZI 1987-04-14

TETRATHIONATE BROTH

Applicant Hardy Media

K number K870634

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KZI 1987-04-03

HORSE BLOOD AGAR, ENRICHED

Applicant bioMerieux, Inc.

K number K871092

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KZI 1987-03-31

CHOCOLATE AGAR

Applicant Mds Laboratories, Inc.

K number K864238

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KZI 1986-10-29

LOMBARD DOWELL AGAR BASE

Applicant Gibco Laboratories Life Technologies, Inc.

K number K864014

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KZI 1986-08-04

VACUTAINER BRAND AGAR SLANT

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K862761

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KZI 1986-07-03

BIOTIS BORDET GENGOU AGAR

Applicant Otisville Biotech, Inc.

K number K862390

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KZI 1986-02-24

BIOTIS COOKED MEAT

Applicant Otisville Biotech, Inc.

K number K860410

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KZI 1985-11-18

TRYPTIC SOY BLOOD AGAR

Applicant R. Kent Richards, Inc.

K number K854454

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KZI 1985-10-31

COLUMBIA 5% BLOOD AGAR

Applicant R. Kent Richards, Inc.

K number K854228

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KZI 1985-10-23

BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K854064

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KZI 1985-08-19

APL TSA WITH 5% SHEEP BLOOD

Applicant Apl Medical Supplies

K number K853236

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KZI 1985-08-19

APL CHOCOLATE AGAR

Applicant Apl Medical Supplies

K number K853233

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KZI 1985-05-08

TRYPTIC SOY AGAR W/5% SHEEP BLOOD

Applicant Preferred Micro-Media

K number K851600

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KZI 1985-04-30

CHOCOLATE AGAR

Applicant Preferred Micro-Media

K number K851588

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KZI 1985-03-25

CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL

Applicant Rapid City Regional Hospital, Inc.

K number K850724

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KZI 1985-03-16

ENRICHED CULTURE MEDIUM

Applicant Roseville Medical Laboratoriesu

K number K850735

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KZI 1984-08-20

BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG

Applicant Otisville Biotech, Inc.

K number K843065

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KZI 1984-05-31

CHOCOLATE AGAR

Applicant The Montana Deaconess Medical Center

K number K841749

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KZI 1984-05-31

SHEEP BLOOD AGAR

Applicant The Montana Deaconess Medical Center

K number K841748

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KZI 1984-05-31

CHOCOLATE AGAR

Applicant Microline Scientific

K number K841586

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KZI 1984-05-21

ENRICHED CULTURE MED. TRYPTIC SOY AGAR

Applicant Microline Scientific

K number K841838

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KZI 1984-05-21

ENRICHED CULTURE MED. FLUID THIOGLYC0

Applicant Microline Scientific

K number K841837

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KZI 1983-10-04

SELENITE CYSTINE BROTH

Applicant Otisville Biotech, Inc.

K number K832533

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KZI 1983-03-08

FILDES ENRICHMENT SOLUTON

Applicant Gibco Laboratories Life Technologies, Inc.

K number K830383

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KZI 1983-02-09

BLOOD AGAR(TSA W/5% SHEEP BLOOD)

Applicant bioMerieux, Inc.

K number K830078

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KZI 1983-02-09

CHOCOLATE AGAR, ENRICHED

Applicant bioMerieux, Inc.

K number K830074

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KZI 1982-03-16

THIOGLYCOLLATE ENRICHED

Applicant American Laboratory Supply, Inc.

K number K820563

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