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KWIK-STIK™ and LYFO DISK™

EUDAMEDFDA UDI

Class B (EU MDR)

Ref [0534P] KWIK-STIK™ S. cerevisiae ATCC 4098™Model 0534Ref [01148P] KWIK-STIK™ K. pneumoniae NCTC 13442Model 01148Ref [01235K] KWIK-STIK™ S. dysenteriae ATCC 13313™Model 01235Ref [0540P] KWIK-STIK™ B. spizizenii ATCC 19659™Model 0540Ref [0483P] KWIK-STIK™ E. coli ATCC 8739™Model 0483Ref [01009K] KWIK-STIK™ P. aeruginosa ATCC 9721™Model 01009Ref [0489P] KWIK-STIK™ B. pertussis ATCC 8467™Model 0489Ref [01007K] KWIK-STIK™ S. aureus ATCC BAA-1708™Model 01007Ref [0431K] KWIK-STIK™ P. larvae ATCC 9545™Model 0431Ref [0158MRSA] KWIK-STIK™ S. aureus ATCC 700699™Model 0158MRSARef [01023K] KWIK-STIK™ C. coli ATCC 33559™Model 01023Ref [0511K] KWIK-STIK™ A. aceti ATCC 15973™Model 0511Ref [0411P] KWIK-STIK™ A. aphrophilus ATCC 7901™Model 0411Ref [01117K] KWIK-STIK™ K. pneumoniae NCTC 13438Model 01117Ref [01066P] KWIK-STIK™ S. cerevisiae ATCC 18824™Model 01066Ref [0486K] KWIK-STIK™ B. spizizenii ATCC 6633™Model 0486Ref [01263P] KWIK-STIK™ K. pneumoniae ATCC BAA-2814™Model 01263Ref [01117P] KWIK-STIK™ K. pneumoniae NCTC 13438Ref [0496P] KWIK-STIK™ S. aureus ATCC 33591™Model 0496Ref [01172K] KWIK-STIK™ C. neoformans ATCC 13690™Model 01172Ref [01065P] KWIK-STIK™ S. aureus NCTC 12493Model 01065Ref [01266K] KWIK-STIK™ A. baumannii NCTC 13304Model 01266Ref [0435K] KWIK-STIK™ S. pneumoniae ATCC 27336™Model 0435Ref [01247P] KWIK-STIK™ K. pneumoniae ATCC BAA-2524™Model 01247Ref [0510P] KWIK-STIK™ C. krusei ATCC 34135™Model 0510Ref [0602K] KWIK-STIK™ S. equisimilis (G) ATCC 12394™Model 0602Ref [0480P] KWIK-STIK™ S. agalactiae (B) NCTC 8017Model 0480Ref [0543P] KWIK-STIK™ E. coli ATCC 14169™Model 0543Ref [01035K] KWIK-STIK™ S. saprophyticus ATCC 35552™Model 01035Ref [01012K] KWIK-STIK™ H. valbyensis ATCC 58370™Model 01012Ref [0578K] KWIK-STIK™ C. braakii ATCC 51113™Model 0578Ref [0474K] KWIK-STIK™ B. pumilus ATCC BAA-1434™Model 0474Ref [01095P] KWIK-STIK™ S. Newport ATCC 6962™Model 01095Ref [01112L] LYFO DISK™ K. pneumoniae NCTC 13440Model 01112Ref [0580K] KWIK-STIK™ C. sporogenes NCIMB 12343Model 0580Ref [01056K] KWIK-STIK™ S. Bispebjerg ATCC 9842™Model 01056Ref [0599P] KWIK-STIK™ A. baumannii NCIMB 12457Model 0599Ref [0481K] KWIK-STIK™ C. jejuni ATCC 33291™Model 0481Ref [01260P] KWIK-STIK™ E. faecium ATCC 8459™Model 01260Ref [01108K] KWIK-STIK™ C. jeikeium ATCC 43734™Model 01108Ref [0464P] KWIK-STIK™ N. sicca ATCC 29193™Model 0464Ref [0720P] KWIK-STIK™ V. furnissii NCTC 11218Model 0720Ref [0727L] LYFO DISK™ L. monocytogenes ATCC 15313™Model 0727Ref [0906P] KWIK-STIK™ S. aureus ATCC 29737™Model 0906Ref [0702P] KWIK-STIK™ Pseudomonas sp. ATCC 31483™Model 0702Ref [0749P] KWIK-STIK™ C. sputigena ATCC 33612™Model 0749Ref [0689P] KWIK-STIK™ M. luteus ATCC 10240™Model 0689Ref [0669K] KWIK-STIK™ K. rhizophila ATCC 9341a™Model 0669Ref [0647L] LYFO DISK™ H. influenzae ATCC 49247™Model 0647Ref [0803P] KWIK-STIK™ Z. rouxii ATCC 28253™Model 0803Ref [0852K] KWIK-STIK™ S. aureus ATCC 43300™Model 0852Ref [0679K] KWIK-STIK™ E. faecium ATCC 27270™Model 0679Ref [0866P] KWIK-STIK™ N. brasiliensis ATCC 19296™Model 0866Ref [0969L] LYFO DISK™ S. mutans ATCC 35668™Model 0969Ref [0688P] KWIK-STIK™ K. rhizophila ATCC 9341™Model 0688Ref [0944P] KWIK-STIK™ P. mirabilis ATCC 35659™Model 0944Ref [0800L] LYFO DISK™ C. albicans ATCC 24433™Model 0800Ref [0893K] KWIK-STIK™ M. gypseum ATCC 24102™Model 0893Ref [0998L] LYFO DISK™ B. cereus ATCC 10876™Model 0998Ref [0897L] LYFO DISK™ C. tropicalis ATCC 9968™Model 0897Ref [0718L] LYFO DISK™ C. jejuni NCTC 11322Model 0718Ref [0622P] KWIK-STIK™ M. catarrhalis ATCC 8176™Model 0622Ref [0742L] LYFO DISK™ S. maltophilia ATCC 51331™Model 0742Ref [0945L] LYFO DISK™ S. saprophyticus ATCC 49453™Model 0945Ref [0827L] LYFO DISK™ S. aureus ATCC 6538P™Model 0827Ref [0684L] LYFO DISK™ K. pneumoniae ATCC 10031™Model 0684Ref [0759P] KWIK-STIK™ S. maltophilia ATCC 17666™Model 0759Ref [0813P] KWIK-STIK™ L. fermentum ATCC 9338™Model 0813Ref [0839K] KWIK-STIK™ M. morganii ATCC 25830™Model 0839Ref [0867L] LYFO DISK™ V. parvula ATCC 10790™Model 0867Ref [0630K] KWIK-STIK™ S. pasteurianus ATCC 49133™Model 0630Ref [0857L] LYFO DISK™ E. raffinosus ATCC 49464™Model 0857Ref [0992P] KWIK-STIK™ C. glabrata ATCC 2001™Model 0992Ref [0944K] KWIK-STIK™ P. mirabilis ATCC 35659™Ref [0965K] KWIK-STIK™ C. pseudodiphtheriticum ATCC 10700™Model 0965Ref [0228L] LYFO DISK™ P. polymyxa ATCC 43865™Model 0228Ref [0620L] LYFO DISK™ H. influenzae (a) ATCC 9006™Model 0620Ref [0683K] KWIK-STIK™ K. pneumoniae ATCC 4352™Model 0683Ref [0676K] KWIK-STIK™ C. sporogenes ATCC 3584™Model 0676Ref [0743L] LYFO DISK™ S. zooepidemicus ATCC 700400™Model 0743Ref [0227L] LYFO DISK™ I. orientalis ATCC 6258™Model 0227Ref [0911P] KWIK-STIK™ A. faecalis ATCC 35655™Model 0911Ref [0893P] KWIK-STIK™ M. gypseum ATCC 24102™Ref [0650P] KWIK-STIK™ E. hirae ATCC 8043™Model 0650Ref [0987L] LYFO DISK™ C. uniguttulatus ATCC 66033™Model 0987Ref [0703P] KWIK-STIK™ P. gergoviae ATCC 33028™Model 0703Ref [0858L] LYFO DISK™ S. sanguinis ATCC 10556™Model 0858Ref [0741L] LYFO DISK™ S. xylosus ATCC 700404™Model 0741Ref [0754L] LYFO DISK™ B. diminuta ATCC 11568™Model 0754Ref [0986P] KWIK-STIK™ C. glabrata ATCC 66032™Model 0986Ref [0645P] KWIK-STIK™ A. aphrophilus ATCC 49146™Model 0645

by Microbiologics, INC.

Identity

Trade Name
LYFO DISK™ FDA UDI
Generic Name
Multiple bacteria species culture isolate identification control IVD, kit FDA UDI
Device Name
KWIK-STIK™ and LYFO DISK™ EUDAMED
LYFO DISK™ C. albicans ATCC 24433™ FDA UDI
LYFO DISK™ K. pneumoniae NCTC 13440 FDA UDI
LYFO DISK™ H. influenzae (a) ATCC 9006™ FDA UDI
LYFO DISK™ S. saprophyticus ATCC 49453™ FDA UDI
LYFO DISK™ B. cereus ATCC 10876™ FDA UDI
LYFO DISK™ B. diminuta ATCC 11568™ FDA UDI
LYFO DISK™ C. jejuni NCTC 11322 FDA UDI
LYFO DISK™ V. parvula ATCC 10790™ FDA UDI
LYFO DISK™ K. pneumoniae ATCC 10031™ FDA UDI
LYFO DISK™ S. maltophilia ATCC 51331™ FDA UDI
LYFO DISK™ P. polymyxa ATCC 43865™ FDA UDI
LYFO DISK™ S. mutans ATCC 35668™ FDA UDI
LYFO DISK™ S. aureus ATCC 6538P™ FDA UDI
LYFO DISK™ S. zooepidemicus ATCC 700400™ FDA UDI
LYFO DISK™ E. raffinosus ATCC 49464™ FDA UDI
LYFO DISK™ L. monocytogenes ATCC 15313™ FDA UDI
LYFO DISK™ C. uniguttulatus ATCC 66033™ FDA UDI
LYFO DISK™ I. orientalis ATCC 6258™ FDA UDI
LYFO DISK™ C. tropicalis ATCC 9968™ FDA UDI
LYFO DISK™ S. xylosus ATCC 700404™ FDA UDI
LYFO DISK™ S. sanguinis ATCC 10556™ FDA UDI
LYFO DISK™ H. influenzae ATCC 49247™ FDA UDI
Model / Reference
0534 EUDAMED
[0534P] KWIK-STIK™ S. cerevisiae ATCC 4098™ EUDAMED
01148 EUDAMED
[01148P] KWIK-STIK™ K. pneumoniae NCTC 13442 EUDAMED
01235 EUDAMED
[01235K] KWIK-STIK™ S. dysenteriae ATCC 13313™ EUDAMED
0540 EUDAMED
[0540P] KWIK-STIK™ B. spizizenii ATCC 19659™ EUDAMED
0483 EUDAMED
[0483P] KWIK-STIK™ E. coli ATCC 8739™ EUDAMED
01009 EUDAMED
[01009K] KWIK-STIK™ P. aeruginosa ATCC 9721™ EUDAMED
0489 EUDAMED
[0489P] KWIK-STIK™ B. pertussis ATCC 8467™ EUDAMED
01007 EUDAMED
[01007K] KWIK-STIK™ S. aureus ATCC BAA-1708™ EUDAMED
0431 EUDAMED
[0431K] KWIK-STIK™ P. larvae ATCC 9545™ EUDAMED
0158MRSA EUDAMED
[0158MRSA] KWIK-STIK™ S. aureus ATCC 700699™ EUDAMED
01023 EUDAMED
[01023K] KWIK-STIK™ C. coli ATCC 33559™ EUDAMED
0511 EUDAMED
[0511K] KWIK-STIK™ A. aceti ATCC 15973™ EUDAMED
0411 EUDAMED
[0411P] KWIK-STIK™ A. aphrophilus ATCC 7901™ EUDAMED
01117 EUDAMED
[01117K] KWIK-STIK™ K. pneumoniae NCTC 13438 EUDAMED
01066 EUDAMED
[01066P] KWIK-STIK™ S. cerevisiae ATCC 18824™ EUDAMED
0486 EUDAMED
[0486K] KWIK-STIK™ B. spizizenii ATCC 6633™ EUDAMED
01263 EUDAMED
[01263P] KWIK-STIK™ K. pneumoniae ATCC BAA-2814™ EUDAMED
[01117P] KWIK-STIK™ K. pneumoniae NCTC 13438 EUDAMED
0496 EUDAMED
[0496P] KWIK-STIK™ S. aureus ATCC 33591™ EUDAMED
01172 EUDAMED
[01172K] KWIK-STIK™ C. neoformans ATCC 13690™ EUDAMED
01065 EUDAMED
[01065P] KWIK-STIK™ S. aureus NCTC 12493 EUDAMED
01266 EUDAMED
[01266K] KWIK-STIK™ A. baumannii NCTC 13304 EUDAMED
0435 EUDAMED
[0435K] KWIK-STIK™ S. pneumoniae ATCC 27336™ EUDAMED
01247 EUDAMED
[01247P] KWIK-STIK™ K. pneumoniae ATCC BAA-2524™ EUDAMED
0510 EUDAMED
[0510P] KWIK-STIK™ C. krusei ATCC 34135™ EUDAMED
0602 EUDAMED
[0602K] KWIK-STIK™ S. equisimilis (G) ATCC 12394™ EUDAMED
0480 EUDAMED
[0480P] KWIK-STIK™ S. agalactiae (B) NCTC 8017 EUDAMED
0543 EUDAMED
[0543P] KWIK-STIK™ E. coli ATCC 14169™ EUDAMED
01035 EUDAMED
[01035K] KWIK-STIK™ S. saprophyticus ATCC 35552™ EUDAMED
01012 EUDAMED
[01012K] KWIK-STIK™ H. valbyensis ATCC 58370™ EUDAMED
0578 EUDAMED
[0578K] KWIK-STIK™ C. braakii ATCC 51113™ EUDAMED
0474 EUDAMED
[0474K] KWIK-STIK™ B. pumilus ATCC BAA-1434™ EUDAMED
01095 EUDAMED
[01095P] KWIK-STIK™ S. Newport ATCC 6962™ EUDAMED
01112 EUDAMED
[01112L] LYFO DISK™ K. pneumoniae NCTC 13440 EUDAMED
0580 EUDAMED
[0580K] KWIK-STIK™ C. sporogenes NCIMB 12343 EUDAMED
01056 EUDAMED
[01056K] KWIK-STIK™ S. Bispebjerg ATCC 9842™ EUDAMED
0599 EUDAMED
[0599P] KWIK-STIK™ A. baumannii NCIMB 12457 EUDAMED
0481 EUDAMED
[0481K] KWIK-STIK™ C. jejuni ATCC 33291™ EUDAMED
01260 EUDAMED
[01260P] KWIK-STIK™ E. faecium ATCC 8459™ EUDAMED
01108 EUDAMED
[01108K] KWIK-STIK™ C. jeikeium ATCC 43734™ EUDAMED
0464 EUDAMED
[0464P] KWIK-STIK™ N. sicca ATCC 29193™ EUDAMED
0720 EUDAMED
[0720P] KWIK-STIK™ V. furnissii NCTC 11218 EUDAMED
0727 EUDAMED
[0727L] LYFO DISK™ L. monocytogenes ATCC 15313™ EUDAMED
0906 EUDAMED
[0906P] KWIK-STIK™ S. aureus ATCC 29737™ EUDAMED
0702 EUDAMED
[0702P] KWIK-STIK™ Pseudomonas sp. ATCC 31483™ EUDAMED
0749 EUDAMED
[0749P] KWIK-STIK™ C. sputigena ATCC 33612™ EUDAMED
0689 EUDAMED
[0689P] KWIK-STIK™ M. luteus ATCC 10240™ EUDAMED
0669 EUDAMED
[0669K] KWIK-STIK™ K. rhizophila ATCC 9341a™ EUDAMED
0647 EUDAMED
[0647L] LYFO DISK™ H. influenzae ATCC 49247™ EUDAMED
0803 EUDAMED
[0803P] KWIK-STIK™ Z. rouxii ATCC 28253™ EUDAMED
0852 EUDAMED
[0852K] KWIK-STIK™ S. aureus ATCC 43300™ EUDAMED
0679 EUDAMED
[0679K] KWIK-STIK™ E. faecium ATCC 27270™ EUDAMED
0866 EUDAMED
[0866P] KWIK-STIK™ N. brasiliensis ATCC 19296™ EUDAMED
0969 EUDAMED
[0969L] LYFO DISK™ S. mutans ATCC 35668™ EUDAMED
0688 EUDAMED
[0688P] KWIK-STIK™ K. rhizophila ATCC 9341™ EUDAMED
0944 EUDAMED
[0944P] KWIK-STIK™ P. mirabilis ATCC 35659™ EUDAMED
0800 EUDAMED
[0800L] LYFO DISK™ C. albicans ATCC 24433™ EUDAMED
0893 EUDAMED
[0893K] KWIK-STIK™ M. gypseum ATCC 24102™ EUDAMED
0998 EUDAMED
[0998L] LYFO DISK™ B. cereus ATCC 10876™ EUDAMED
0897 EUDAMED
[0897L] LYFO DISK™ C. tropicalis ATCC 9968™ EUDAMED
0718 EUDAMED
[0718L] LYFO DISK™ C. jejuni NCTC 11322 EUDAMED
0622 EUDAMED
[0622P] KWIK-STIK™ M. catarrhalis ATCC 8176™ EUDAMED
0742 EUDAMED
[0742L] LYFO DISK™ S. maltophilia ATCC 51331™ EUDAMED
0945 EUDAMED
[0945L] LYFO DISK™ S. saprophyticus ATCC 49453™ EUDAMED
0827 EUDAMED
[0827L] LYFO DISK™ S. aureus ATCC 6538P™ EUDAMED
0684 EUDAMED
[0684L] LYFO DISK™ K. pneumoniae ATCC 10031™ EUDAMED
0759 EUDAMED
[0759P] KWIK-STIK™ S. maltophilia ATCC 17666™ EUDAMED
0813 EUDAMED
[0813P] KWIK-STIK™ L. fermentum ATCC 9338™ EUDAMED
0839 EUDAMED
[0839K] KWIK-STIK™ M. morganii ATCC 25830™ EUDAMED
0867 EUDAMED
[0867L] LYFO DISK™ V. parvula ATCC 10790™ EUDAMED
0630 EUDAMED
[0630K] KWIK-STIK™ S. pasteurianus ATCC 49133™ EUDAMED
0857 EUDAMED
[0857L] LYFO DISK™ E. raffinosus ATCC 49464™ EUDAMED
0992 EUDAMED
[0992P] KWIK-STIK™ C. glabrata ATCC 2001™ EUDAMED
[0944K] KWIK-STIK™ P. mirabilis ATCC 35659™ EUDAMED
0965 EUDAMED
[0965K] KWIK-STIK™ C. pseudodiphtheriticum ATCC 10700™ EUDAMED
0228 EUDAMED
[0228L] LYFO DISK™ P. polymyxa ATCC 43865™ EUDAMED
0620 EUDAMED
[0620L] LYFO DISK™ H. influenzae (a) ATCC 9006™ EUDAMED
0683 EUDAMED
[0683K] KWIK-STIK™ K. pneumoniae ATCC 4352™ EUDAMED
0676 EUDAMED
[0676K] KWIK-STIK™ C. sporogenes ATCC 3584™ EUDAMED
0743 EUDAMED
[0743L] LYFO DISK™ S. zooepidemicus ATCC 700400™ EUDAMED
0227 EUDAMED
[0227L] LYFO DISK™ I. orientalis ATCC 6258™ EUDAMED
0911 EUDAMED
[0911P] KWIK-STIK™ A. faecalis ATCC 35655™ EUDAMED
[0893P] KWIK-STIK™ M. gypseum ATCC 24102™ EUDAMED
0650 EUDAMED
[0650P] KWIK-STIK™ E. hirae ATCC 8043™ EUDAMED
0987 EUDAMED
[0987L] LYFO DISK™ C. uniguttulatus ATCC 66033™ EUDAMED
0703 EUDAMED
[0703P] KWIK-STIK™ P. gergoviae ATCC 33028™ EUDAMED
0858 EUDAMED
[0858L] LYFO DISK™ S. sanguinis ATCC 10556™ EUDAMED
0741 EUDAMED
[0741L] LYFO DISK™ S. xylosus ATCC 700404™ EUDAMED
0754 EUDAMED
[0754L] LYFO DISK™ B. diminuta ATCC 11568™ EUDAMED
0986 EUDAMED
[0986P] KWIK-STIK™ C. glabrata ATCC 66032™ EUDAMED
0645 EUDAMED
[0645P] KWIK-STIK™ A. aphrophilus ATCC 49146™ EUDAMED
0800L FDA UDI
01112L FDA UDI
0620L FDA UDI
0945L FDA UDI
0998L FDA UDI
0754L FDA UDI
0718L FDA UDI
0867L FDA UDI
0684L FDA UDI
0742L FDA UDI
0228L FDA UDI
0969L FDA UDI
0827L FDA UDI
0743L FDA UDI
0857L FDA UDI
0727L FDA UDI
0987L FDA UDI
0227L FDA UDI
0897L FDA UDI
0741L FDA UDI
0858L FDA UDI
0647L FDA UDI
Description
LYFO DISK™ C. albicans ATCC 24433™ FDA UDI
LYFO DISK™ K. pneumoniae NCTC 13440 FDA UDI
LYFO DISK™ H. influenzae (a) ATCC 9006™ FDA UDI
LYFO DISK™ S. saprophyticus ATCC 49453™ FDA UDI
LYFO DISK™ B. cereus ATCC 10876™ FDA UDI
LYFO DISK™ B. diminuta ATCC 11568™ FDA UDI
LYFO DISK™ C. jejuni NCTC 11322 FDA UDI
LYFO DISK™ V. parvula ATCC 10790™ FDA UDI
LYFO DISK™ K. pneumoniae ATCC 10031™ FDA UDI
LYFO DISK™ S. maltophilia ATCC 51331™ FDA UDI
LYFO DISK™ P. polymyxa ATCC 43865™ FDA UDI
LYFO DISK™ S. mutans ATCC 35668™ FDA UDI
LYFO DISK™ S. aureus ATCC 6538P™ FDA UDI
LYFO DISK™ S. zooepidemicus ATCC 700400™ FDA UDI
LYFO DISK™ E. raffinosus ATCC 49464™ FDA UDI
LYFO DISK™ L. monocytogenes ATCC 15313™ FDA UDI
LYFO DISK™ C. uniguttulatus ATCC 66033™ FDA UDI
LYFO DISK™ I. orientalis ATCC 6258™ FDA UDI
LYFO DISK™ C. tropicalis ATCC 9968™ FDA UDI
LYFO DISK™ S. xylosus ATCC 700404™ FDA UDI
LYFO DISK™ S. sanguinis ATCC 10556™ FDA UDI
LYFO DISK™ H. influenzae ATCC 49247™ FDA UDI

Identifiers

Catalog Number
0800L FDA UDI
01112L FDA UDI
0620L FDA UDI
0945L FDA UDI
0998L FDA UDI
0754L FDA UDI
0718L FDA UDI
0867L FDA UDI
0684L FDA UDI
0742L FDA UDI
0228L FDA UDI
0969L FDA UDI
0827L FDA UDI
0743L FDA UDI
0857L FDA UDI
0727L FDA UDI
0987L FDA UDI
0227L FDA UDI
0897L FDA UDI
0741L FDA UDI
0858L FDA UDI
0647L FDA UDI
Primary DI / UDI-DI
20845357012979 EUDAMED
20845357037033 EUDAMED
30845357040030 EUDAMED
20845357013150 EUDAMED
20845357011330 EUDAMED
30845357029189 EUDAMED
20845357011781 EUDAMED
30845357029127 EUDAMED
30845357009976 EUDAMED
20845357001652 EUDAMED
30845357029516 EUDAMED
30845357012341 EUDAMED
20845357009382 EUDAMED
30845357036309 EUDAMED
20845357032922 EUDAMED
30845357011610 EUDAMED
20845357041290 EUDAMED
20845357036296 EUDAMED
20845357011910 EUDAMED
30845357037863 EUDAMED
20845357032878 EUDAMED
30845357042447 EUDAMED
30845357010064 EUDAMED
20845357040507 EUDAMED
20845357012306 EUDAMED
30845357014307 EUDAMED
20845357011217 EUDAMED
20845357013242 EUDAMED
30845357031434 EUDAMED
30845357029271 EUDAMED
30845357013744 EUDAMED
30845357011078 EUDAMED
20845357035152 EUDAMED
10845357036046 EUDAMEDFDA UDI
30845357013829 EUDAMED
30845357032486 EUDAMED
20845357014232 EUDAMED
30845357011252 EUDAMED
20845357040996 EUDAMED
30845357035890 EUDAMED
20845357010791 EUDAMED
10845357019360 EUDAMEDFDA UDI
10845357014648 EUDAMEDFDA UDI
10845357022902 EUDAMEDFDA UDI
10845357024364 EUDAMEDFDA UDI
10845357018073 EUDAMEDFDA UDI
10845357017380 EUDAMEDFDA UDI
10845357021288 EUDAMEDFDA UDI
10845357016246 EUDAMEDFDA UDI
10845357017779 EUDAMEDFDA UDI
10845357003673 EUDAMEDFDA UDI
10845357023534 EUDAMEDFDA UDI
10845357020144 EUDAMEDFDA UDI
10845357017809 EUDAMEDFDA UDI
10845357021011 EUDAMEDFDA UDI
10845357017533 EUDAMEDFDA UDI
10845357024050 EUDAMEDFDA UDI
10845357003642 EUDAMEDFDA UDI
10845357022070 EUDAMEDFDA UDI
10845357017748 EUDAMEDFDA UDI
10845357021042 EUDAMEDFDA UDI
10845357015393 EUDAMEDFDA UDI
20845357017424 EUDAMED
20845357022237 EUDAMED
20845357016892 EUDAMED
20845357017936 EUDAMED
20845357016496 EUDAMED
30845357015809 EUDAMED
20845357019466 EUDAMED
30845357020919 EUDAMED
30845357016073 EUDAMED
20845357021230 EUDAMED
20845357016441 EUDAMED
20845357022855 EUDAMED
30845357021923 EUDAMED
20845357014683 EUDAMED
20845357018230 EUDAMED
20845357019800 EUDAMED
30845357020520 EUDAMED
30845357014901 EUDAMED
20845357024163 EUDAMED
30845357022869 EUDAMED
30845357023408 EUDAMED
30845357016196 EUDAMED
30845357015977 EUDAMED
20845357022404 EUDAMED
20845357021919 EUDAMED
20845357015468 EUDAMED
20845357016939 EUDAMED
20845357024002 EUDAMED
20845357015314 EUDAMED
Basic UDI-DI
0845357005349W EUDAMED
0845357001148WR EUDAMED
0845357001235WM EUDAMED
0845357005409R EUDAMED
084535700483A6 EUDAMED
0845357001009WA EUDAMED
084535700489AJ EUDAMED
0845357001007W6 EUDAMED
0845357004319K EUDAMED
084535700158MRSAQC EUDAMED
0845357001023W4 EUDAMED
0845357005119J EUDAMED
0845357004119D EUDAMED
0845357001117WE EUDAMED
0845357001066WN EUDAMED
084535700486AC EUDAMED
0845357001263WS EUDAMED
084535700496AF EUDAMED
0845357001172WN EUDAMED
0845357001065WL EUDAMED
0845357001266WY EUDAMED
0845357004359T EUDAMED
0845357001247WU EUDAMED
0845357005109G EUDAMED
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FDA Product Code
JTR FDA UDI
EMDN Code
W01040699 CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER EUDAMED
W01040601 QC STRAINS BACTERIOLOGY EUDAMED
GMDN Term
Multiple bacteria species culture isolate identification control IVD, kit FDA UDI

Classification

Device Class
Class B EUDAMED
Class I FDA UDI
Regulation Number
866.2480 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ and LYFO DISK™ by Microbiologics, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple bacteria species culture isolate identification control IVD, kit.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Microbiologics, INC.
EUDAMED SRN
US-MF-000000466
Authorised Representative
MediMark Europe Sarl. FR-AR-000000182

Sources (113)

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