FDA.reportPublic FDA data

IMMCO DIAGNOSTICS

Primary DI
00845714001192
Brand
IMMCO DIAGNOSTICS
Company
IMMCO DIAGNOSTICS, INC.
Model
1115X
Catalog number
1115X
Device description
Anti-Reticulin Antibody (ARA) 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
DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845714001192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714001192008457140011928457140011920845714001192

GMDN Terms#

Term, Definition table
TermDefinition
Endomysium antibody (EMA) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-endomysial antibodies (anti-EMA) 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
00813545029029GBM IgG Test SystemSCIMEDX CORPORATIONDBL2023-06-13
00813545026684MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026691MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026776MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026783MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026790MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026806MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026813MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026820MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026837MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026844MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026851MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026868MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026875MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026882MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026899MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027124MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027131MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027223MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027261MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027278MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027285MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027292MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027308MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027315MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027322MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027339MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027346MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027353MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027360MeDiCaSCIMEDX CORPORATIONDBL2020-12-01