FDA.reportPublic FDA data

RIDA® CCD-Inhibitor

Primary DI
04049095260049
Brand
RIDA® CCD-Inhibitor
Company
R-Biopharm AG
Model
ZA0601
Device description
The RIDA® CCD-Inhibitor is an accessory for use in in vitro diagnostics for the inhibition of anti-CCD IgE in human serum and plasma.
Published
2023-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
DHLProtein, Complement, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHLProtein, Complement, Antigen, Antiserum, ControlImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049095260049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049095260049040490952600494049095260049

GMDN Terms#

Term, Definition table
TermDefinition
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergens in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
321850323
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049095070495RIDASCREEN® Pancreatic Elastase ELISAG09038USAG09038USA2026-03-26
04049095030079RIDASCREEN® Norovirus 3rd GenerationC1401USC1401US2019-05-08
04049095160356RIDA®GENE Norovirus GI/GIIPG1445PG14452019-05-08
04049095110023RIDASCREEN® Entamoeba histolytica IgGK1721K17212019-05-08
04049095110511RIDASCREEN® Echinococcus IgGK7621K76212019-05-08
04049095110528RIDASCREEN® Taenia solium IgGK7721K77212019-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10634853000169Fungal SerologyMICROBIOLOGICS INC.DHL2022-09-26
B1761080Antiserum to Human ProperdinKENT LABORATORIES INCDHL2016-09-24
B1761082Anti Human Properdin FITCKENT LABORATORIES INCDHL2016-09-24
B1761212Anti Human C3b Inactivator FITCKENT LABORATORIES INCDHL2016-09-24
00817273020457DiamedixDIAMEDIX CORPORATIONDHL2016-09-21
00817273020426DiamedixDIAMEDIX CORPORATIONDHL2016-09-20
00817273020433DiamedixDIAMEDIX CORPORATIONDHL2016-09-20
00817273020440DiamedixDIAMEDIX CORPORATIONDHL2016-09-20