FDA.reportPublic FDA data

EliA Rib-P Well

Primary DI
07333066014869
Brand
EliA Rib-P Well
Company
Phadia AB
Model
DECC055210
Catalog number
DECC055210
Device description
EliA Rib-P Well
Published
2021-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQAANTI-RIBOSOMAL P ANTIBODIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQAAnti-Ribosomal P AntibodiesImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202540000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202540000EliA Rib-PPhadia AB2021-09-13MQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066014869PackageGS12In Commercial Distribution
07333066015538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066014869073330660148697333066014869
07333066015538073330660155387333066015538

GMDN Terms#

Term, Definition table
TermDefinition
Ribosomal phosphoprotein antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to ribosomal phosphoprotein in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+469999999999xx@xx.xx

Regulatory Flags#

DUNS number
354019424
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333066014524EliA U1RNP WellDECC055010DECC0550102016-09-23
07333066014562EliA CENP WellDECC055050DECC0550502016-09-23
07333066014623EliA RNP70 WellDECC055110DECC0551102016-09-23
07333066014630EliA GBM WellDECC055140DECC0551402016-09-23
07333066014678EliA Celikey IgG WellDECC055180DECC0551802016-09-23
07333066014715EliA Cardiolipin IgA WellDECC055280DECC0552802016-09-23
07333066014746EliA ß2-Glycoprotein I IgA WellDECC055310DECC0553102016-09-23
07333066014777EliA PR3S WellDECC055360DECC0553602016-09-23
07333066014784EliA MPOS WellDECC055370DECC0553702016-09-23
07333066014791EliA GliadinDP IgA WellDECC055380DECC0553802016-09-23
07333066014807EliA GliadinDP IgG WellDECC055390DECC0553902016-09-23
07333066014814EliA RF IgM WellDECC056000DECC0560002016-09-23
07333066014852EliA M2 WellDECC056490DECC0564902016-09-23
07333066014593EliA Symphony WellDECC055080DECC0550802016-09-23
07333066016115EliA SymphonyS WellDECC056710DECC0567102020-06-30
07333066015798EliA CCP WellDECC066150DECC0661502026-01-29
07333066024202EliA IgG Calibrator WellDECC066090DECC0660902026-01-29
07333066024226EliA Dummy WellDECC066100DECC0661002026-01-29
07333066024240EliA IgA Calibrator WellDECC066160DECC0661602026-01-29
07333066024271EliA IgM Calibrator WellDECC066270DECC0662702026-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.MQA2023-12-14
07333066015538EliA Rib-P WellPhadia ABMQA2021-10-08
04049016027225Anti-ribosomal P Proteins ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMQA2016-09-24
04049016083139EUROLINE ENA ProfilePlus 4 (IgG)EUROIMMUN Medizinische Labordiagnostika AGMQA2016-09-24
04049016084785EUROLINE ENA ProfilePlus 4 (IgG)EUROIMMUN Medizinische Labordiagnostika AGMQA2016-09-24
04049016124900EUROLINE ENA Profile 9 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGMQA2016-09-24
04049016124917EUROLINE ENA Profile 9 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGMQA2016-09-24
00847865000086BioPlex 2200BIO-RAD LABORATORIES, INC.MQA2016-09-12
00847865000093BioPlex 2200BIO-RAD LABORATORIES, INC.MQA2016-09-12
00847865001342BioPlex 2200BIO-RAD LABORATORIES, INC.MQA2016-09-12
00847865002448BioPlex 2200BIO-RAD LABORATORIES, INC.MQA2016-09-12
00847865002721BioPlex 2200BIO-RAD LABORATORIES, INC.MQA2016-09-12
00847865012331BioPlex 2200BIO-RAD LABORATORIES, INC.MQA2016-09-12
08426950506348QUANTA Lite® Ribosome P ELISAINOVA DIAGNOSTICS, INC.MQA2016-08-31