FDA.reportPublic FDA data

AccuDiag ™

Primary DI
00894175000022
Brand
AccuDiag ™
Company
Diagnostic Automation, Inc.
Model
DACD-1423-2
Catalog number
1423-2
Device description
AccuDiag ™ Borrelia burgdorferi IgG/IgM is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
Published
2021-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LSRReagent, Borrelia Serological Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSRReagent, Borrelia Serological ReagentMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894175000022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894175000022008941750000228941750000220894175000022

GMDN Terms#

Term, Definition table
TermDefinition
Borrelia burgdorferi immunoglobulin G (IgG)/IgM 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 immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00between 2 and 8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8185913030onestep@rapidtest.com

Regulatory Flags#

DUNS number
878252071
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054026446AccuDiag™ T3 ELISA KitDACD3144-153144-152026-03-02
00850082766024AccuDiag™ Mycoplasma pneumoniae IgG ELISADACD8042-28042-22026-03-02
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA DACD2506-22506-22026-02-27
00850049545433AccuDiag™ Prolactin (PRL) ELISADACD4226-154226-152026-01-30
00850054026712AccuDiag™ LH ELISADACD4225-154225-152026-01-30
00894175000800AccuDiag™ Progesterone ELISADACD2077-152077-152026-01-30
00850054026569QMedix™DACD5102-25102-22024-04-23
00850049545723AccuDiag™ Insulin ELISADACD1606-151606-152026-01-27
00850049545815AccuDiag™ Human Growth Hormone (HGH) ELISADACD1901-151901-152026-01-27
00850054026255AccuDiag™ C-Peptide ELISA KitDACD1293-151293-152026-01-27
00850054026682AccuDiag™ Estradiol ELISA DACD2046-152046-152026-01-27
00850054026705 AccuDiag™ FSH ELISADACD4224-154224-152026-01-27
00850082766017AccuDiag™ Free Estriol ELISA DACD3171-153171-152026-01-27
00894175000770AccuDiag™ 17-alpha-OH Progesterone ELISADACD1292-151292-152026-01-27
00894175000824AccuDiag™ ANST (Androstenedione) ELISADACD1038-151038-152026-01-27
10850049545492QMedix™DACD104110-1-19104110-1-192025-12-24
10850082766007QMedix™DACD113030-1-19113030-1-192025-12-24
00850049545501Diagnostic Automation, Inc.DAI SF2100SF21002025-12-24
00850054026392Diagnostic Automation, Inc.DAI SF2600SF26002025-12-24
00850049545495QMedix™DACD104110-1-19104110-1-192025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850049545259AccuDiag ™Diagnostic Automation, Inc.LSR2024-03-06
00850054026378QMedix™Diagnostic Automation, Inc.LSR2024-01-31
04048474028096B. burgdorferi IgG/IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
04048474028102Borrelia burgdorferi IgG (Lyme) ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
04048474028119Borrelia burgdorferi IgM (Lyme) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
00840239028099B. burgdorferi IgG/IgM ELISADRG International IncLSR2023-08-24
00840239028105Borrelia burgdorferi IgG (Lyme) ELISADRG International IncLSR2023-08-24
00840239028112Borrelia burgdorferi IgM (Lyme) ELISA DRG International IncLSR2023-08-24
EVIRBTCFDK1Borrelia All-In-One ViraChip Deca KitViramed Biotech AGLSR2022-11-08
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B350GSD0110250Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitGold Standard Diagnostics CorporationLSR2022-09-24
B350GSD0110260Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitGold Standard Diagnostics CorporationLSR2022-09-24
00845533001854ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test SystemZEUS SCIENTIFIC, INC.LSR2022-04-27
B350GSD0110270Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test KitGold Standard Diagnostics CorporationLSR2021-07-20
B350GSD0110220Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test KitGold Standard Diagnostics CorporationLSR2020-07-01
B350GSD0110230Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test KitGold Standard Diagnostics CorporationLSR2020-07-01
05391516746779Trinity BiotechCLARK LABORATORIES, INC.LSR2019-12-26
05391516746816Trinity BiotechCLARK LABORATORIES, INC.LSR2019-12-26
30014613337799SofiaQUIDEL CORPORATIONLSR2019-12-10
05391516747486Trinity BiotechCLARK LABORATORIES, INC.LSR2019-11-05
05391516746625MarDxCLARK LABORATORIES, INC.LSR2019-10-25
05391516747134Trinity BiotechCLARK LABORATORIES, INC.LSR2019-08-06
05391516747547Trinity BiotechCLARK LABORATORIES, INC.LSR2019-08-06
03610520506394BioPlex 2200BIO-RAD LABORATORIES, INC.LSR2019-05-13
03610520506455BioPlex 2200BIO-RAD LABORATORIES, INC.LSR2019-04-30
03610520506462BioPlex 2200BIO-RAD LABORATORIES, INC.LSR2019-04-30
30014613202981SofiaQUIDEL CORPORATIONLSR2018-08-07
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