FDA.reportPublic FDA data

NA

Primary DI
05056080500065
Brand
NA
Company
REMEL EUROPE LIMITED
Model
R30855001
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GNCAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNCAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080500065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080500065050560805000655056080500065

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401322295600ITechnicalSupport@remel.com

Regulatory Flags#

DUNS number
232600853
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056080500928Shigella boydii polyvalent 1 (1-6) Agglutinating SerumR301639012026-05-05
05056080501024NAR301650012016-12-09
05056080501888Wellcolex E.coli O157R309595012021-07-21
05056080501598Proteus OX2 Agglutinating SerumR301657012021-07-21
05056080500126NAR308553012016-09-24
05056080500317NAR309577012016-09-24
05056080500324NAR309578012016-09-24
05056080500331NAR309579012016-09-24
05056080500348NAR309580012016-09-24
05056080500379NAR309583012016-09-24
05056080500409NAR309586012016-09-24
05056080500591NAR301606012016-09-24
05056080500607NAR301607012016-09-24
05056080500614NAR301608012016-09-24
05056080500638NAR301610012016-09-24
05056080500645NAR301611012016-09-24
05056080500652NAR301612012016-09-24
05056080500713NAR301618012016-09-24
05056080500768NAR301623012016-09-24
05056080500867NAR301633012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817978020011Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020028Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020035Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020080Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020103Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020110Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020226Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020233Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020240Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020257Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020264Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020271Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020288Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020295Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020301Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020318Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020325Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020332Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020349Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020356Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020363Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020370Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020387Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020394Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020400Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020417Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020424Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020431Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020448Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17
00817978020455Vision 2PRO-LAB, INCORPORATEDGNC2016-11-17