FDA.reportPublic FDA data

Proteus OX2 Agglutinating Serum

Primary DI
05056080501598
Brand
Proteus OX2 Agglutinating Serum
Company
REMEL EUROPE LIMITED
Model
R30165701
Published
2021-07-21
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
GSYAntisera, Fluorescent, All Globulins, Proteus Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GSYAntisera, Fluorescent, All Globulins, Proteus Spp.Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080501598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080501598050560805015985056080501598

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Rickettsia species (spotted fever group) total antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to one or multiple species of the rickettsial bacteria associated with spotted fever in a clinical specimen. Rickettsia species intended to be detected may include Rickettsia rickettsii, R. akari, R. conorii, R. sibirica, R. australis, R. japonica, R. africae, R. honei and/or R. felis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401256694238microbiology.techsupport.uk@thermofisher.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
05056080500065NAR308550012016-09-24
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
05056080501604Proteus OX19 Agglutinating SerumREMEL EUROPE LIMITEDGSY2021-07-21
05056080501611Proteus OXK Agglutinating SerumREMEL EUROPE LIMITEDGSY2021-07-21
00695684012007PROTEUS OXK ANTIGENGERMAINE LABORATORIES, INCGSY2016-04-27
00695684012014PROTEUS OX2 ANTIGENGERMAINE LABORATORIES, INCGSY2016-04-27
00695684012021PROTEUS OX19 ANTIGENGERMAINE LABORATORIES, INCGSY2016-04-27
00695684013035PROTEUS POLY ANTISERUMGERMAINE LABORATORIES, INCGSY2016-04-27