Vision 2

GUDID 00817978021001

Salmonella O:27

PRO-LAB, INCORPORATED

Multiple Salmonella species culture isolate antigen IVD, reagent

• Primary Device ID: 00817978021001
• NIH Device Record Key: 69b4592a-1dcf-4547-8c3a-554a29e5c8e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vision 2
• Version Model Number: PLA100
• Company DUNS: 960418395
• Company Name: PRO-LAB, INCORPORATED
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 512-832-9145
• Email: support@pro-lab.us
• Phone: 512-832-9145
• Email: support@pro-lab.us

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817978021001 [Primary]

FDA Product Code

• GNC: Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-17

On-Brand Devices [Vision 2]

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