KWIK-STIK™ 0104U

GUDID 30845357000157

KWIK-STIK™ S. agalactiae (B III) ATCC 12403™

MICROBIOLOGICS INC.

Multiple bacteria species culture isolate identification control IVD, kit

• Primary Device ID: 30845357000157
• NIH Device Record Key: cb2e9f2b-d240-4694-a2a1-98d1e0e8441c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KWIK-STIK™
• Version Model Number: 0104U
• Catalog Number: 0104U
• 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	10845357000146 [Primary]
GS1	20845357000143 [Package]; Contains: 10845357000146; Package: 2 Pack [2 Units]; In Commercial Distribution
GS1	30845357000157 [Package]; Contains: 10845357000146; Package: 6 Pack [6 Units]; In Commercial Distribution

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 [KWIK-STIK™]

• 20845357043102: KWIK-STIK™ N. gonorrhoeae CDC P681E
• 20845357043034: KWIK-STIK™ B. fulva ATCC 24474™
• 30845357042843: KWIK-STIK™ L. johnsonii ATCC 11506™
• 20845357042662: KWIK-STIK™ B. multivorans ATCC BAA-247™
• 30845357042614: KWIK-STIK™ B. cenocepacia ATCC BAA-245™
• 20845357042433: KWIK-STIK™ A. baumannii NCTC 13304
• 30845357041723: KWIK-STIK™ E. coli NCTC 13353
• 30845357041679: KWIK-STIK™ A. terreus ATCC 1012™
• 10845357041606: KWIK-STIK™ S. aureus BD 3097
• 10845357041590: KWIK-STIK™ S. aureus BD 19
• 10845357041583: KWIK-STIK™ S. aureus BD 16
• 10845357041576: KWIK-STIK™ S. aureus BD 9
• 10845357041569: KWIK-STIK™ S. aureus BD 1
• 10845357041552: KWIK-STIK™ S. aureus BD 131
• 10845357041545: KWIK-STIK™ S. aureus BD 2800
• 10845357041538: KWIK-STIK™ S. aureus BD 11
• 10845357041521: KWIK-STIK™ S. aureus BD 2937
• 10845357041514: KWIK-STIK™ S. aureus BD 797
• 10845357041507: KWIK-STIK™ S. aureus BD 2952
• 20845357041290: KWIK-STIK™ K. pneumoniae ATCC BAA-2814™
• 20845357041252: KWIK-STIK™ L. brevis ATCC 14869™
• 30845357041037: KWIK-STIK™ E. coli ATCC BAA-1429™
• 20845357040996: KWIK-STIK™ E. faecium ATCC 8459™
• 20845357040958: KWIK-STIK™ E. coli CDC AR-0346
• 30845357040740: KWIK-STIK™ C. auris CDC B11903
• 20845357040705: KWIK-STIK™ S. Nottingham NCTC 7832
• 20845357040668: KWIK-STIK™ M. f. racemosus ATCC 22365™
• 20845357040637: KWIK-STIK™ C. sphaerospermum ATCC 11289™
• 30845357040610: KWIK-STIK™ A. pullulans ATCC 11942™
• 20845357040576: KWIK-STIK™ P. corylophilum ATCC 9784™
• 30845357040481: KWIK-STIK™ K. pneumoniae ATCC BAA-2524™
• 20845357040477: KWIK-STIK™ S. aureus (1) ATCC 12598™
• 20845357040446: KWIK-STIK™ K. pneumoniae NCTC 13439
• 30845357040405: KWIK-STIK™ E. coli NCTC 13846
• 20845357040392: KWIK-STIK™ L. innocua ATCC 51742™
• 30845357040320: KWIK-STIK™ E. coli ATCC BAA-2452™
• 30845357040306: KWIK-STIK™ K. pneumoniae CDC AR-0039
• 30845357040283: KWIK-STIK™ K. pneumoniae CDC AR-0066
• 20845357040279: KWIK-STIK™ N. gonorrhoeae CDC 10328
• 20845357040248: KWIK-STIK™ T. pinophilus ATCC 11797™
• 20845357040194: KWIK-STIK™ C. fetus ATCC 27374™
• 20845357040088: KWIK-STIK™ V. parahaemolyticus (o2:k3) NCTC 10885
• 20845357040057: KWIK-STIK™ S. agalactiae (III) ATCC BAA-22™
• 20845357040026: KWIK-STIK™ S. dysenteriae ATCC 13313™
• 30845357039898: KWIK-STIK™ E. coli ATCC 51739™
• 20845357039365: KWIK-STIK™ E. coli ATCC BAA-2523™
• 30845357039348: KWIK-STIK™ N. gonorrhoeae CDC 10329
• 20845357039242: KWIK-STIK™ N. gonorrhoeae CDC SPJ-15
• 30845357039225: KWIK-STIK™ N. gonorrhoeae CDC SPL-4
• 30845357039195: KWIK-STIK™ N. gonorrhoeae CDC F-28