FDA.reportPublic FDA data

Anti-Cardiolipin IgG/IgM ELISA

Primary DI
00404847435870
Brand
Anti-Cardiolipin IgG/IgM ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
N/A
Catalog number
EIA-3587
Device description
Anti-Cardiolipin IgG / IgM ELISA is a test system for the quantitative measurement of IgG and IgM class autoantibodies against cardiolipin in human serum or plasma.
Published
2019-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIDSYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955449000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955449000ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAYAmerican Laboratory Products Co., Ltd.1996-05-23MID

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00404847435870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00404847435870004048474358704048474358700404847435870

GMDN Terms#

Term, Definition table
TermDefinition
Anticardiolipin antibody 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 one or multiple classes of antibodies to cardiolipin in a clinical specimen, using an enzyme immunoassay (EIA) method.

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(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
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
false
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
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08426951011193HemosIL CL Anti-Cardiolipin IgMINSTRUMENTATION LABORATORY COMPANYMID2026-04-08
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
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
00845714002786IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MID2016-12-09
00845714002922IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MID2016-12-09
00845714002823IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MID2016-11-15
00845714002953IMMCO 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