FDA.reportPublic FDA data

Immco Diagnostics, Inc

Primary DI
00845714004827
Brand
Immco Diagnostics, Inc
Company
IMMCO DIAGNOSTICS, INC.
Model
5170
Catalog number
5170
Device description
Enhanced Anti-RNA POL lll Antibody ELISA
Published
2018-07-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NYOAutoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYOAutoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii AntibodyImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845714004827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714004827008457140048278457140048270845714004827

GMDN Terms#

Term, Definition table
TermDefinition
RNA polymerase III antibody (anti-Pol III) 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 anti-RNA polymerase III antibodies (anti-Pol III) in a clinical specimen, using an enzyme immunoassay (EIA) 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
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
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
07333066015583EliA RNA Pol III WellPhadia ABNYO2021-10-08
07333066014913EliA RNA Pol III WellPhadia ABNYO2021-10-08
08426950506362QUANTA Lite® RNA Pol III ELISAINOVA DIAGNOSTICS, INC.NYO2016-08-31