Vision 2

GUDID 00817978025481

E. coli O2

PRO-LAB, INCORPORATED

Multiple Salmonella species culture isolate antigen IVD, reagent
Primary Device ID00817978025481
NIH Device Record Keyb05cbf46-6421-499c-ad01-3b18a6342037
Commercial Distribution StatusIn Commercial Distribution
Brand NameVision 2
Version Model NumberPLA548
Company DUNS960418395
Company NamePRO-LAB, INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone512-832-9145
Emailsupport@pro-lab.us
Phone512-832-9145
Emailsupport@pro-lab.us

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817978025481 [Primary]

FDA Product Code

GNCAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-11-16

On-Brand Devices [Vision 2]

00817978026136Widal & Weil Felix Positive control Proteus OXK
00817978026129Widal & Weil Felix Positive control Proteus OX19
00817978026112Widal & Weil Felix Positive control Proteus OX2
00817978025887Widal & Weil Felix Positive control Salmonella Typhi H
00817978025870Widal & Weil Felix Positive control Salmonella Typhi O
00817978025856Widal & Weil Felix Positive control Salmonella Paratyphi C-O
00817978025832Widal & Weil Felix Positive control Salmonella Paratyphi B-O
00817978025818Widal & Weil Felix Positive control Salmonella Paratyphi A-O
00817978025481E. coli O2
00817978025474E. coli O1 : K1
00817978025467E. coli H7
00817978025450E. coli O157
00817978025412E. coli O 112a O 112c : K 66
00817978025405E. coli O 28 : K 73
00817978025399E. coli O 20a O 20b : K 84
00817978025382E. coli O 18a O 18c : K77
00817978025375E. coli (O&K) Polyvalent III
00817978025368E. coli O 128: K 67
00817978025351E. coli O 127: K 63
00817978025344E. coli O 126: K 71
00817978025337E. coli O 125: K 70
00817978025320E. coli O 124: K 72
00817978025313E. coli O 86: K 61
00817978025306E. coli (O&K) Polyvalent II
00817978025290E. coli O 119: K 169
00817978025283E. coli O 114: K -
00817978025276E. coli O 111: K 58
00817978025269E. coli O 78: K 80
00817978025252E. coli O 55: K 59
00817978025245E. coli O 44: K 74
00817978025238E. coli O 25: K 60
00817978025221E. coli O 25: K 11
00817978025214E. coli (O&K) Polyvalent I
00817978024958Vibrio cholerae O141
00817978024941Vibrio cholerae O139
00817978024934Vibrio cholerae Ogawa
00817978024927Vibrio cholerae Inaba
00817978024910Vibrio cholerae O1 Polyvalent
00817978024422Shigella boydii Phase II
00817978024415Shigella boydii Phase I
00817978024286Shigella boydii type 18
00817978024279Shigella boydii type 17
00817978024262Shigella boydii type 16
00817978024255Shigella boydii type 15
00817978024248Shigella boydii type 14
00817978024231Shigella boydii type 13
00817978024224Shigella boydii type 12
00817978024217Shigella boydii type 11
00817978024200Shigella boydii type 10
00817978024194Shigella boydii type 9

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