FDA.reportPublic FDA data

IMMCO DIAGNOSTICS

Primary DI
00845714004162
Brand
IMMCO DIAGNOSTICS
Company
IMMCO DIAGNOSTICS, INC.
Model
2505
Catalog number
2505
Device description
Mounting Medium
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
LKJAntinuclear Antibody, Antigen, Control
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, ControlImmunology2
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, ControlImmunology2
LKJAntinuclear Antibody, Antigen, ControlImmunology2
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)Immunology2
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060157000
K883883000
K883915000
K883949000
K884400000
K891098000
K891099000
K912551000
K913360000
K982898000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060157000IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFAImmco Diagnostics, Inc.2006-05-25MVM
K883883000ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)Immco Diagnostics, Inc.1988-10-27LKJ
K883915000AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)Immco Diagnostics, Inc.1988-10-19DBL
K883949000ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)Immco Diagnostics, Inc.1988-10-27LKJ
K884400000ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)Immco Diagnostics, Inc.1988-11-04DHN
K891098000ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)Immco Diagnostics, Inc.1989-03-22DBL
K891099000ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC)Immco Diagnostics, Inc.1989-03-22DBL
K912551000ANTI-ENDOMYSIAL ANTIBODY TESTImmco Diagnostics, Inc.1993-06-09DBL
K913360000ANTI-RETICULIN ANTIBODY (ARA) TESTImmco Diagnostics, Inc.1994-09-26DBL
K982898000IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEMImmco Diagnostics, Inc.1998-11-30MOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845714004162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714004162008457140041628457140041620845714004162

GMDN Terms#

Term, Definition table
TermDefinition
Microscopy mounting medium IVDA substance intended to be used to create a seal between a microscope slide, clinical specimen and/or coverslip to preserve the specimen and enhance image quality during microscopic examination.

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
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
00845714000003IMMCO DIAGNOSTICS110211022016-09-21
00845714000010IMMCO DIAGNOSTICS110311032016-09-21
00845714000089IMMCO DIAGNOSTICS113611362016-09-21
00845714000096IMMCO DIAGNOSTICS1136-961136-962016-09-21
00845714000218IMMCO DIAGNOSTICS117511752016-09-21
00845714000249IMMCO DIAGNOSTICS 1102-601102-602016-09-21
00845714000287IMMCO DIAGNOSTICS110711072016-09-21
00845714000393IMMCO DIAGNOSTICS112511252016-09-21
00845714000430IMMCO DIAGNOSTICS113411342016-09-21
00845714000461IMMCO DIAGNOSTICS1136-2501136-2502016-09-21
00845714000829IMMCO DIAGNOSTICS1102-1201102-1202016-09-21
00845714000836IMMCO DIAGNOSTICS1102-120X1102-120X2016-09-21
00845714000843IMMCO DIAGNOSTICS1102-60X1102-60X2016-09-21
00845714000867IMMCO DIAGNOSTICS 1102X1102X2016-09-21
00845714000874IMMCO DIAGNOSTICS1103-2401103-2402016-09-21
00845714000881IMMCO DIAGNOSTICS 1103-240X1103-240X2016-09-21
00845714000898IMMCO DIAGNOSTICS1103-4801103-4802016-09-21
00845714000904IMMCO DIAGNOSTICS1103-480X1103-480X2016-09-21
00845714000928IMMCO DIAGNOSTICS1103X1103X2016-09-21
00845714001017IMMCO DIAGNOSTICS1107-11107-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333066024240EliA IgA Calibrator WellPhadia ABMVM2026-01-29
07333066023977EliA IgA Calibrator WellPhadia ABMVM2026-01-29
04049016161592IFA: Oesophagus (Monkey) IgAEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
04049016161608IFA: Oesophagus (Monkey) IgAEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
04049016161615IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
04049016161622IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
00845533002011Endomysium (Primate esophagus)ZEUS SCIENTIFIC, INC.MVM2025-10-17
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
04250289504942AESKUSLIDES® ANA HEp-2-GammaAesku.Diagnostics GmbH & Co. KGDHN2025-05-27
00845533001960Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.MOB2025-05-12
00845533001977Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)ZEUS SCIENTIFIC, INC.MOB2025-05-12
04250289513487AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2025-04-06
04250289513562AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2025-04-06
B3507207900Gold Standard Diagnostics Is-ANA Screen ELISA Test KitGold Standard Diagnostics CorporationLKJ2025-02-26
08426950627692QUANTA Flash PR3 ReagentsINOVA DIAGNOSTICS, INC.MOB2024-12-13
08059304340215dIFine ANA HEp-2 ClassifierVISIA LAB SRLDHN2024-11-08
04049016144595IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2024-05-17
08426950627685QUANTA Flash® MPO ReagentsINOVA DIAGNOSTICS, INC.MOB2023-12-14
04049016159704EUROPLUS Granulocyte Mosaic 32EUROIMMUN Medizinische Labordiagnostika AGMOB2023-10-05
G5229023441ANA/HEp-2 IgG IFA 96 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023451ANA/HEp-2 IgG IFA 180 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023601ANA/HEp-2 IgG IFA 600 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023701ANA/HEp-2 IgG IFA 1200 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023901ANA/HEp-2 IgG IFA 120 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229024201Anti-nDNA IgG IFA 96 TestHemagen Diagnostics, Inc.DHN2023-10-05
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