Primary Device ID | 00817978020363 |
NIH Device Record Key | f4a2bd42-7d61-4efb-9400-9c840f6b476f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Vision 2 |
Version Model Number | PLA036 |
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 |
Phone | 512-832-9145 |
support@pro-lab.us | |
Phone | 512-832-9145 |
support@pro-lab.us |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817978020363 [Primary] |
GNC | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-11-17 |
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 |