FDA.reportPublic FDA data

IMMCO DIAGNOSTICS

Primary DI
00845714000560
Brand
IMMCO DIAGNOSTICS
Company
IMMCO DIAGNOSTICS, INC.
Model
1140-2
Catalog number
1140-2
Device description
Anti-neutrophil Cytoplasmic Antibody (ANCA) IFA Kit
Published
2016-09-21
Public version status
Update
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
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845714000560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714000560008457140005608457140005600845714000560

GMDN Terms#

Term, Definition table
TermDefinition
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassayA 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 a fluorescent immunoassay method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
1-800-537-8378INFO@IMMCO.COM

Regulatory Flags#

DUNS number
079935300
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00845714002922IMMCO DIAGNOSTICS251425142016-12-09
00845714000935IMMCO DIAGNOSTICS110411042016-09-21
00845714000942IMMCO DIAGNOSTICS 1104X1104X2016-09-21
00845714000959IMMCO DIAGNOSTICS110511052016-09-21
00845714000966IMMCO DIAGNOSTICS1105X1105X2016-09-21
00845714003257IMMCO DIAGNOSTICS221322132016-09-23
00845714003707IMMCO DIAGNOSTICS221622162016-11-16
00845714003714IMMCO DIAGNOSTICS221722172016-09-23
00845714000638IMMCO DIAGNOSTICS1152G1152G2016-09-21
00845714000645IMMCO DIAGNOSTICS1152M1152M2016-09-21
00845714001024IMMCO DIAGNOSTICS1107-1X1107-1X2016-09-21
00845714001994IMMCO DIAGNOSTICS2152-32152-32016-09-23
00845714003332IMMCO DIAGNOSTICS219121912016-09-23
00845714003363IMMCO DIAGNOSTICS219021902016-09-23
00845714003370IMMCO DIAGNOSTICS218921892016-09-23
00845714003387IMMCO DIAGNOSTICS218621862016-09-23
00845714003448IMMCO DIAGNOSTICS2167-82167-82016-09-23
00845714003462IMMCO DIAGNOSTICS250025002016-10-27
00845714003547IMMCO DIAGNOSTICS2152-102152-102016-09-23
00845714003554IMMCO DIAGNOSTICS215421542016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840239027771ANCA Screen 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
04250289510356AESKUSLIDES ANCA EthanolAesku.Diagnostics GmbH & Co. KGMOB2018-05-25
04250289510363AESKUSLIDES ANCA FormalinAesku.Diagnostics GmbH & Co. KGMOB2018-05-25
04250289510370AESKUSLIDES ANCA EthanolAesku.Diagnostics GmbH & Co. KGMOB2018-05-25