FDA.reportPublic FDA data

IMMCO DIAGNOSTICS

Primary DI
00845714002953
Brand
IMMCO DIAGNOSTICS
Company
IMMCO DIAGNOSTICS, INC.
Model
5305
Catalog number
5305
Device description
Serum Diluent
Published
2016-11-15
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
MIDSystem, Test, Anticardiolipin Immunological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIDSystem, Test, Anticardiolipin ImmunologicalImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845714002953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714002953008457140029538457140029530845714002953

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, manualA buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens.

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
false
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
08430793040716Aptiva® APS IgG ReagentINOVA DIAGNOSTICS, INC.MID2024-03-11
08430793040853Aptiva® APS IgM ReagentINOVA DIAGNOSTICS, INC.MID2024-03-11
04048474027884Cardiolipin IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2023-08-29
04048474027891Cardiolipin IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2023-08-29
04048474027907Cardiolipin IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2023-08-29
04048474035889Anti-Cardiolipin IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2023-08-29
00840239035875Anti-Cardiolipin IgG/IgM ELISADRG International IncMID2023-08-25
00840239035882Anti-Cardiolipin IgA ELISADRG International IncMID2023-08-25
00840239035899Anti-Cardiolipin Screen ELISADRG International IncMID2023-08-25
00840239027887Cardiolipin IgG ELISADRG International IncMID2023-08-24
00840239027900Cardiolipin IgA ELISADRG International IncMID2023-08-24
07333066014197EliA APS Positive Control 2500/5000Phadia ABMID2020-12-09
08426951289240QUANTA Flash® aCL IgM ReagentsINOVA DIAGNOSTICS, INC.MID2019-09-27
08426951289288QUANTA Flash® aCL IgA ReagentsINOVA DIAGNOSTICS, INC.MID2019-09-27
08426951289295QUANTA Flash® aCL IgG ReagentsINOVA DIAGNOSTICS, INC.MID2019-09-27
04048474035872Anti-Cardiolipin IgG/IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
04048474035896Anti-Cardiolipin Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
00404847435870Anti-Cardiolipin IgG/IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
00404847435894Anti-Cardiolipin Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
B24235CAAHUE010Anti-Cardiolipin-A ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.MID2017-08-28
04250289503044AESKULISA® Cardiolipin-Check Aesku.Diagnostics GmbH & Co. KGMID2017-02-28
04250289503051AESKULISA® Cardiolipin-A Aesku.Diagnostics GmbH & Co. KGMID2017-02-28
04250289503068AESKULISA® Cardiolipin-GM Aesku.Diagnostics GmbH & Co. KGMID2017-02-28
00845714002823IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MID2016-11-15
04250289500821AESKULISA® Cardiolipin-Check Aesku.Diagnostics GmbH & Co. KGMID2016-09-27
04250289500838AESKULISA® Cardiolipin-A Aesku.Diagnostics GmbH & Co. KGMID2016-09-27
04250289500845AESKULISA® Cardiolipin-GM Aesku.Diagnostics GmbH & Co. KGMID2016-09-27
00816879020151Autostat II Anti-Cardiolipin IgGHYCOR BIOMEDICAL LLCMID2016-09-26
00816879020168Autostat II Anti-Cardiolipin IgMHYCOR BIOMEDICAL LLCMID2016-09-26
00816879020182Autostat II Anti-Cardiolipin ScreenHYCOR BIOMEDICAL LLCMID2016-09-26