Acumedia Manufacturers, Inc.
Acumedia Manufacturers, Inc. holds FDA 510(k) medical device clearances, first cleared 1981, most recent 1988, with 8 FDA device recalls on record.
Top product codes for Acumedia Manufacturers, Inc.
FDA recalls by Acumedia Manufacturers, Inc.
- Z-0283-2019 — Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
- Z-0284-2019 — Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
- Z-2221-2017 — Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
- Z-2212-2017 — Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
- Z-1093-2017 — Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
- Z-2213-2017 — Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is present, gelatin is hydrolyzed and loses its gelling characteristic.
- Z-2584-2017 — Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.
- Z-2214-2017 — Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk, and other materials, where uniform composition of media is important. Beef Extract Powder is relied upon for biochemical studies, particularly fermentation reactions because of its independence from ferment-able substances. Several media containing Beef Extract Powder are recommended in standard methods for multiple application.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Acumedia Manufacturers, Inc.
1–100 of 177- K881486 — DNASE TEST AGAR
- K881522 — DEXTROSE AGAR
- K881523 — DEXTROSE TRYPTONE BROTH
- K881524 — DERMATOPHYTE TEST MEDIUM
- K881525 — COOKED MEAT MEDIUM
- K881526 — CHAPMAN STONE MEDIUM
- K881527 — CASMAN MEDIUM BASE
- K881528 — CASEIN PEPTONE, LOW VITAMIN
- K881529 — CARY AND BLAIR TRANSPORT MEDIUM
- K881530 — BRILLIANT GREEN AGAR W/SULFADIAZINE
- K881531 — BLOOD AGAR BASE, IMPROVED
- K881532 — BLOOD AGAR BASE W/LOW PH
- K881533 — BLOOD AGAR BASE NO. 2
- K881534 — ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR
- K881535 — ANTIBIOTIC MEDIUM #6
- K881536 — ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR
- K881537 — ANTIBIOTIC MEDIUM #19
- K881538 — ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR
- K881539 — AMIES TRANSPORT MEDIUM
- K881540 — FLO AGAR
- K881541 — GELATIN
- K881542 — HEART INFUSION AGAR
- K881543 — LETHEEN AGAR
- K881544 — LITTMAN AGAR
- K881545 — MALT EXTRACT
- K881546 — MALT EXTRACT AGAR
- K881547 — MITIS SALIVARIUS AGAR
- K881548 — MPH AGAR
- K881549 — MYCOLOGICAL AGAR W/LOW PH
- K881550 — OF BASAL MEDIUM
- K881551 — PHENOL RED BROTH BASE
- K881552 — PROTEOSE NO. 3 AGAR
- K881553 — RUSSELL DOUBLE SUGAR AGAR
- K881554 — SKIM MILK DEHYDRATED
- K881555 — TINSDALE AGAR BASE
- K881556 — TRICHOMONAS BROTH
- K881557 — TRYPTONE
- K881558 — TRYPTOSE AGAR
- K881559 — UREA AGAR BASE
- K881560 — UREA BROTH
- K881561 — TERGITOL 7 BROTH
- K881562 — TRYPTOSE BLOOD AGAR BASE
- K881563 — TRYPTOSE PHOSPHATE BROTH
- K881564 — TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT
- K881565 — INHIBITORY MOLD AGAR
- K881566 — HEMOGLOBIN POWDER
- K881567 — WILKENS CHALGREN AGAR
- K881568 — WILKENS CHALGREN BROTH
- K881569 — STUARTS TRANSPORT MEDIUM
- K881570 — SABOURAUD MALTOSE AGAR
- K881571 — YM BROTH
- K881572 — XL AGAR BASE
- K881573 — PHYTONE YEAST EXTRACT AGAR
- K881574 — W-L DIFFERENTIAL MEDIUM
- K881575 — SELECTIVE STREPTOCOCCUS AGAR
- K881576 — SELENITE BROTH
- K881577 — MODIFIED SELECTIVE STREPTOCOCCUS AGAR
- K881578 — STREPTOSEL
- K881579 — AMIES TRANSPORT MEDIUM W/O CHARCOAL
- K842100 — MACCONKEY AGAR, PLUS
- K842101 — COBA AGAR
- K834204 — MIDDLEBROOK & COHN 7H11 AGAR BASE
- K834205 — MIDDLEBROOK & COHN 7H10 AGAR BASE
- K834206 — EUGONIC AGAR
- K833291 — JH PEPTONE AGAR
- K833292 — LACTABACILLUS AGAR W/O TWEEN80
- K833299 — BRUCELLA AGAR MODIFIED
- K833300 — SABOURAUD BHI AGAR
- K833296 — SABOURAUD DEXTROSE AGAR, EMMONS
- K833301 — FEELEY-GORMAN AGAR
- K833201 — SIMMONS CITRATE AGAR
- K833202 — MOELLER DECARBOXYLASE BROTH
- K833203 — DEOXYCHOLATE LACTOSE AGAR
- K833204 — DEOXYCHOLATE CITRATE AGAR
- K833205 — YERSINIA SELECTIVE AGAR
- K833206 — TECH AGAR
- K833207 — AK AGAR 2
- K833208 — MR-VP BROTH
- K833209 — ACIDICASE-BB1
- K833210 — LACTOSE
- K833211 — BILE SALTS MIXTURE
- K833212 — MAC CONKEY AGAR WITHOUT CRYSTAL VIOLET
- K833213 — KLIGLER IRON AGAR
- K833214 — DEXTROSE
- K833215 — BEEF EXTRACT
- K833216 — MOTILITY TEST MEDIUM
- K833217 — STANDARD METHOD BROTH
- K833218 — YEAST BEEF AGAR-ANTIBIOTIC MED.4
- K833219 — STAPHYLOCOCCUS AGAR 10
- K833220 — LOWENSTEIN-JENSEN MEDIUM BASE
- K832568 — INDOLE NITRATE MEDIUM
- K832569 — INFUSION BROTH
- K832570 — EXTRACT BROTH
- K832571 — BILE ESCULIN AZIDE AGAR
- K832572 — BILE ESCULIN AGAR
- K832573 — C.L.E.D. MEDIUM
- K832574 — BTB LACTOSE AGAR
- K832575 — ANTIBIOTIC ASSAY BROTH
- K832576 — BASE AGAR
- K832577 — SEED AGAR
Data sourced from openFDA. This site is unofficial and independent of the FDA.