FDA.reportPublic FDA data

ANCA Screen IgG ELISA

Primary DI
00840239027771
Brand
ANCA Screen IgG ELISA
Company
DRG International Inc
Model
EIA-2777
Catalog number
EIA-2777
Device description
The ANCA Screen ELISA test system is intended for the qualitative detection of anti-Myeloperoxidase and/or anti-Proteinase-3 IgG antibody in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of anti-neutrophil cytoplasmic antibodies (ANCA). MPO and/or PR-3 may be associated with autoimmune disorders such as Wegener’s Granulamatosis, ICGN, MPA and PRS.
Published
2023-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964448000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964448000PROTEINASE-3 IGG ELISA TEST SYSTEMZeus Scientific, Inc.1997-04-10MOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239027771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239027771008402390277718402390277710840239027771

GMDN Terms#

Term, Definition table
TermDefinition
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple anti-neutrophil cytoplasmic antibodies (ANCA) in a clinical specimen, using an enzyme immunoassay (EIA) 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
9735647555corpoffice@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
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
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059304340239dIFine ANCA ClassifierVISIA LAB SRLMOB2025-06-27
00845533001984Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.MOB2025-06-11
00845533001991Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) ZEUS SCIENTIFIC, INC.MOB2025-06-11
00845533001960Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.MOB2025-05-12
00845533001977Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)ZEUS SCIENTIFIC, INC.MOB2025-05-12
08426950627692QUANTA Flash PR3 ReagentsINOVA DIAGNOSTICS, INC.MOB2024-12-13
08426950627685QUANTA Flash® MPO ReagentsINOVA DIAGNOSTICS, INC.MOB2023-12-14
04049016159704EUROPLUS Granulocyte Mosaic 32EUROIMMUN Medizinische Labordiagnostika AGMOB2023-10-05
04048474027761Myeloperoxidase IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMOB2023-08-29
04048474027778ANCA Screen IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMOB2023-08-29
04048474027785Proteinase-3 IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMOB2023-08-29
00840239035967c-ANCA (PR3) ELISADRG International IncMOB2023-08-25
00840239035974pANCA (MPO) ELISADRG International IncMOB2023-08-25
00840239027764Myeloperoxidase IgG ELISADRG International IncMOB2023-08-23
00840239027788Proteinase-3 IgG ELISADRG International IncMOB2023-08-23
00813545029036MBO IgG Test SystemSCIMEDX CORPORATIONMOB2023-06-13
00813545029043PR3 IgG Test SystemSCIMEDX CORPORATIONMOB2023-06-13
B3507204300Gold Standard Diagnostics Is-Anti-MPO (P-ANCA) IgG ELISA Test KitGold Standard Diagnostics CorporationMOB2022-12-03
B3507204400Gold Standard Diagnostics Is-Anti-PR3 (C-ANCA) IgG ELISA Test KitGold Standard Diagnostics CorporationMOB2022-12-03
07350008750098OMNERA 500AArcoma ABMOB2022-03-30
00894175000404AccuDiag ™ Diagnostic Automation, Inc.MOB2021-08-09
07333066014166EliA ANCA/GBM Positive Control 2500/5000Phadia ABMOB2020-12-09
04048474035971pANCA (MPO) ELISA)DRG Instruments Gesellschaft mit beschränkter HaftungMOB2019-06-10
00404847435979pANCA (MPO) ELISA)DRG Instruments Gesellschaft mit beschränkter HaftungMOB2019-06-10
04049016072102IFA: Granulocyte Mosaic 13EUROIMMUN Medizinische Labordiagnostika AGMOB2019-06-06
04048474035964c-ANCA (PR3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungMOB2019-06-05
00404847435962c-ANCA (PR3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungMOB2019-06-05
04049016108535IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108542IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108559IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04