LYFO DISK™ 0101L

GUDID 10845357000061

LYFO DISK™ S. zooepidemicus ATCC 43079™

MICROBIOLOGICS INC.

Multiple bacteria species culture isolate identification control IVD, kit

• Primary Device ID: 10845357000061
• NIH Device Record Key: c0741ebc-48ed-4d1e-ae22-7d1ee7d7d659
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LYFO DISK™
• Version Model Number: 0101L
• Catalog Number: 0101L
• Company DUNS: 060467826
• Company Name: MICROBIOLOGICS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10845357000061 [Primary]

FDA Product Code

• JTR: KIT, QUALITY CONTROL FOR CULTURE MEDIA

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-08
• Device Publish Date: 2020-04-30

On-Brand Devices [LYFO DISK™]

• 10845357043099: LYFO DISK™ N. gonorrhoeae CDC P681E
• 10845357043020: LYFO DISK™ B. fulva ATCC 24474™
• 10845357042825: LYFO DISK™ L. johnsonii ATCC 11506™
• 10845357042658: LYFO DISK™ B. multivorans ATCC BAA-247™
• 10845357042627: LYFO DISK™ B. cenocepacia ATCC BAA-245™
• 10845357042429: LYFO DISK™ A. baumannii NCTC 13304
• 10845357041705: LYFO DISK™ E. coli NCTC 13353
• 10845357041699: LYFO DISK™ A. terreus ATCC 1012™
• 10845357041286: LYFO DISK™ K. pneumoniae ATCC BAA-2814™
• 10845357041279: LYFO DISK™ L. brevis ATCC 14869™
• 10845357041019: LYFO DISK™ E. coli ATCC BAA-1429™
• 10845357040982: LYFO DISK™ E. faecium ATCC 8459™
• 10845357040944: LYFO DISK™ E. coli CDC AR-0346
• 10845357040722: LYFO DISK™ C. auris CDC B11903
• 10845357040692: LYFO DISK™ S. Nottingham NCTC 7832
• 10845357040654: LYFO DISK™ M. f. racemosus ATCC 22365™
• 10845357040623: LYFO DISK™ C. sphaerospermum ATCC 11289™
• 10845357040593: LYFO DISK™ A. pullulans ATCC 11942™
• 10845357040562: LYFO DISK™ P. corylophilum ATCC 9784™
• 10845357040494: LYFO DISK™ K. pneumoniae ATCC BAA-2524™
• 10845357040463: LYFO DISK™ S. aureus (1) ATCC 12598™
• 10845357040418: LYFO DISK™ E. coli NCTC 13846
• 10845357040388: LYFO DISK™ L. innocua ATCC 51742™
• 10845357040333: LYFO DISK™ E. coli ATCC BAA-2452™
• 10845357040265: LYFO DISK™ N. gonorrhoeae CDC 10328
• 10845357040234: LYFO DISK™ T. pinophilus ATCC 11797™
• 10845357040203: LYFO DISK™ C. fetus ATCC 27374™
• 10845357040104: LYFO DISK™ V. parahaemolyticus (o2:k3) NCTC 10885
• 10845357040067: LYFO DISK™ S. agalactiae (III) ATCC BAA-22™
• 10845357040043: LYFO DISK™ S. dysenteriae ATCC 13313™
• 10845357039887: LYFO DISK™ E. coli ATCC 51739™
• 10845357039382: LYFO DISK™ E. coli ATCC BAA-2523™
• 10845357039351: LYFO DISK™ N. gonorrhoeae CDC 10329
• 10845357039269: LYFO DISK™ N. gonorrhoeae CDC SPJ-15
• 10845357039238: LYFO DISK™ N. gonorrhoeae CDC SPL-4
• 10845357039207: LYFO DISK™ N. gonorrhoeae CDC F-28
• 10845357039177: LYFO DISK™ N. gonorrhoeae CDC F-18
• 10845357039047: LYFO DISK™ P. mirabilis ATCC 29906™
• 10845357039016: LYFO DISK™ V. vulnificus ATCC 29307™
• 10845357038880: LYFO DISK™ S. boydii (2) ATCC 8700™
• 10845357038798: LYFO DISK™ E. coli (O157:H7) ATCC 43890™
• 10845357038675: LYFO DISK™ E. cloacae ATCC BAA-2341™
• 10845357038613: LYFO DISK™ P. rubens ATCC 11709™
• 10845357038484: LYFO DISK™ R. pickettii ATCC 700591™
• 10845357038453: LYFO DISK™ C. bifermentans NCTC 506
• 10845357038422: LYFO DISK™ L. anisa ATCC 35292™
• 10845357038361: LYFO DISK™ E. coli NCTC 13167
• 10845357038330: LYFO DISK™ E. coli NCTC 13216
• 10845357038279: LYFO DISK™ L. monocytogenes ATCC 35152™
• 10845357038248: LYFO DISK™ S. epidermidis ATCC 35984™