FDA.reportPublic FDA data

BioPlex 2200

Primary DI
00847865012331
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
SW4.1_V2
Catalog number
6651170D
Device description
ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJMANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS
LKJANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
LKOANTI-RNP ANTIBODY, ANTIGEN AND CONTROL
LLLEXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL
LRMANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL
MQAANTI-RIBOSOMAL P ANTIBODIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, ControlsImmunology2
LKJAntinuclear Antibody, Antigen, ControlImmunology2
LKOAnti-Rnp Antibody, Antigen And ControlImmunology2
LLLExtractable Antinuclear Antibody, Antigen And ControlImmunology2
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, ControlImmunology2
MQAAnti-Ribosomal P AntibodiesImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865012331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865012331008478650123318478650123310847865012331

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antinuclear antibody (ANA) screening IVD, kit, multiplexA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using a multiplex method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723TechSupport.USSD@bio-rad.com

Regulatory Flags#

DUNS number
884513334
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA Diagnostic Automation, Inc.LLL2026-02-27
B3507207900Gold Standard Diagnostics Is-ANA Screen ELISA Test KitGold Standard Diagnostics CorporationLKJ2025-02-26
00850054026569QMedix™Diagnostic Automation, Inc.LJM2024-04-23
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LKO2023-12-14
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LLL2023-12-14
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.MQA2023-12-14
00840239035769Anti-SS-B ELISADRG International IncLJM2023-10-09
04048474039016ENA-6-Profile ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-31
04048474041170ANA Detect ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-31
04048474027730ANA Screen IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-29
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
00840239039019ENA-6-Profile ELISADRG International IncLLL2023-08-25
00840239041173ANA Detect ELISADRG International IncLJM2023-08-25
00840239027870Jo-1 IgG ELISADRG International IncLJM2023-08-24
00840239034380Anti-dsDNA IgG ELISADRG International IncLRM2023-08-24
00840239035622ANA-8-Screen ELISADRG International IncLJM2023-08-24