FDA.reportPublic FDA data

Anti-SS-A (Ro) ELISA

Primary DI
00840239035738
Brand
Anti-SS-A (Ro) ELISA
Company
DRG International Inc
Model
EIA-3573
Catalog number
EIA-3573
Device description
Anti-SS-A (Ro) ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-A (52 kDa and 60 kDa) in human serum or plasma.
Published
2023-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, ControlsImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962054000ORGENTEC ANTI-SS-A(RO) ELISAAmerican Laboratory Products Co., Ltd.1996-11-15LJM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239035738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239035738008402390357388402390357380840239035738

GMDN Terms#

Term, Definition table
TermDefinition
Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple extractable nuclear antigens (ENA) 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
9735647555corpoffice@drg-international.com

Regulatory Flags#

DUNS number
075150847
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
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026569QMedix™Diagnostic Automation, Inc.LJM2024-04-23
00840239035769Anti-SS-B ELISADRG International IncLJM2023-10-09
04048474041170ANA Detect ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-31
04048474027747DNA (ds) IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027792ENA Screen (entractable nuclear antigen) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027808ENA-6-Profile ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027822SSA (Ro) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027839SSB (La) IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027846Sm IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027853Sm RNP IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027860Scl-70 IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027877Jo-1 IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474035803Anti-Scl-70 ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
00084023903579Anti-SS-B ELISA DRG International IncLJM2023-08-25
00840239035776Anti-Sm ELISADRG International IncLJM2023-08-25
00840239035783Anti-RNP/Sm ELISA DRG International IncLJM2023-08-25
00840239035806Anti-Scl-70 ELISADRG International IncLJM2023-08-25
00840239035813Anti-Jo-1 ELISADRG International IncLJM2023-08-25
00840239041173ANA Detect ELISADRG International IncLJM2023-08-25
00840239027870Jo-1 IgG ELISADRG International IncLJM2023-08-24
00840239035622ANA-8-Screen ELISADRG International IncLJM2023-08-24
00840239035639ANA-8-Profile ELISADRG International IncLJM2023-08-24
00840239027740DNA (ds) IgG ELISADRG International IncLJM2023-08-23
00840239027795ENA Screen (entractable nuclear antigen) ELISA DRG International IncLJM2023-08-23
00840239027801ENA-6-Profile ELISADRG International IncLJM2023-08-23
00840239027825SSA (Ro) ELISA DRG International IncLJM2023-08-23
00840239027832SSB (La) IgG ELISADRG International IncLJM2023-08-23
00840239027849Sm IgG ELISADRG International IncLJM2023-08-23
00840239027856Sm RNP IgG ELISADRG International IncLJM2023-08-23
00840239027863Sci-70 IgG ELISADRG International IncLJM2023-08-23