FDA.reportPublic FDA data

IMMCO DIAGNOSTICS

Primary DI
00845714000997
Brand
IMMCO DIAGNOSTICS
Company
IMMCO DIAGNOSTICS, INC.
Model
1106-6X
Catalog number
1106-6X
Device description
Anti-nDNA Antibody 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
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845714000997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714000997008457140009978457140009970845714000997

GMDN Terms#

Term, Definition table
TermDefinition
Native DNA antibody (anti-nDNA) 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 native DNA (anti-nDNA) 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
04250289504942AESKUSLIDES® ANA HEp-2-GammaAesku.Diagnostics GmbH & Co. KGDHN2025-05-27
04250289513487AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2025-04-06
04250289513562AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2025-04-06
08059304340215dIFine ANA HEp-2 ClassifierVISIA LAB SRLDHN2024-11-08
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
00813545026561MeDiCaSCIMEDX CORPORATIONDHN2020-12-01
00813545026578MeDiCaSCIMEDX CORPORATIONDHN2020-12-01
00813545026905MeDiCaSCIMEDX CORPORATIONDHN2020-11-04
00813545026912MeDiCaSCIMEDX CORPORATIONDHN2020-11-04
04260186125096HELIOSAesku.Systems GmbH & Co. KGDHN2020-03-02
00845714002045Immco Diagnostics, IncIMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714002052Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714002069Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714004100Immco Diagnostics Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714004117Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
04250289503020AESKULISA® ANA-HEp-2 Aesku.Diagnostics GmbH & Co. KGDHN2017-03-02
04250289503501AESKULISA® ANA-HEp-2 Aesku.Diagnostics GmbH & Co. KGDHN2017-02-28
04250289504461AESKUSLIDES® ANA-HEp-2 Aesku.Diagnostics GmbH & Co. KGDHN2017-02-28
04250289504935AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2017-02-28
10862534000300ANA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20
10862534000317ANA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20
10862534000324ANA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20
42601861205090HELIOSAesku.Systems GmbH & Co. KGDHN2016-09-27
04250289500005AESKUSLIDES® ANA-HEp-2 Aesku.Diagnostics GmbH & Co. KGDHN2016-09-27
04250289500579AESKULISA® ANA-HEp-2 Aesku.Diagnostics GmbH & Co. KGDHN2016-09-27