FDA.reportPublic FDA data

EL-ANCA: anti-PR3

Primary DI
00854473003231
Brand
EL-ANCA: anti-PR3
Company
THERA-TEST LABORATORIES, INC
Model
104-115
Catalog number
104-115
Device description
ANTI-PROTEINASE-3 (PR3) ANTIBODIES (C-ANCA) ELISA TEST KIT, 96 TESTS
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061376000EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3Theratest Laboratories, Inc.2006-07-20MOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854473003231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854473003231008544730032318544730032310854473003231

GMDN Terms#

Term, Definition table
TermDefinition
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) 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 anti-neutrophil cytoplasmic antibodies (ANCA) to proteinase 3 (PR3) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
194336954
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
00854473003255EL-anti-TPO104-119104-1192016-07-28
00854473003347EL-ANA PROFILES: ANA/8103-005103-0052023-07-06
00854473003354EL-ANA PROFILES: ANA/6101-005101-0052023-07-06
00854473003323EL-Anti-SARS-CoV-2 IgM104-129104-1292020-05-19
00854473003330EL-Anti-SARS-CoV-2 IgG104-130104-1302020-05-19
00854473003316EL-Anti-SARS-CoV-2104-128104-1282020-05-04
00854473003002EL-ANA PROFILES: EL-ANAscr100-002100-0022016-08-15
00854473003019EL-anti-CCP/2104-122104-1222016-08-15
00854473003026EL-ANA Profiles: anti-dsDNA104-201104-2012016-08-15
00854473003033EL-RF/3 IgM, IgG, IgA303-305303-3052016-08-15
00854473003040EL-B2GPI IgM, IgG, IgA401-404401-4042016-08-15
00854473003057EL-ANA PROFILES: EL-ANAscr100-004100-0042016-08-15
00854473003064EL-RF IgM301-305301-3052016-08-15
00854473003071EL-ANA PROFILES: ANA/9104-005104-0052016-08-15
00854473003088EL-ANA PROFILES: ANA/7102-005102-0052016-08-15
00854473003095EL-ANA Profiles: anti-ssDNA104-101104-1012016-08-15
00854473003101EL-ANA Profiles: anti-Sm104-501104-5012016-08-15
00854473003118EL-ANA Profiles: anti-RNP/Sm104-601104-6012016-08-15
00854473003125EL-ANA Profiles: anti-SSA104-301104-3012016-08-15
00854473003149EL-ANA Profiles: anti-HISTONE104-701104-7012016-08-15