FDA.reportPublic FDA data

Autostat II Anti-GBM

Primary DI
00816879020137
Brand
Autostat II Anti-GBM
Company
HYCOR BIOMEDICAL LLC
Model
FGA13
Device description
96 well ELISA for the detection of anti-GBM antibodies in human serum
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991890000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991890000AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISACogent Diagnotics , Ltd.1999-08-09MVJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816879020137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879020137008168790201378168790201370816879020137

GMDN Terms#

Term, Definition table
TermDefinition
Glomerular basement membrane antibody (Goodpasture 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 antibodies to glomerular basement membrane (anti-GBM) or Goodpasture antibodies 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
800-382-2527Customerservices-us@hycorbiomedical.com

Regulatory Flags#

DUNS number
010558476
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00810053950135NOVEOS Almond, Amygdalus communisF0208634040Z2026-07-29
00810053950296NOVEOS Bos d 8 Casein, MilkF078C63250-3Z2026-07-29
00810053950319NOVEOS Lobster, Homarus gammarusF0808632520Z2026-07-29
00810053950449NOVEOS Ara h 8 PR-10, PeanutF352C63343Z2026-07-29
00810053950456NOVEOS Ara h 1, PeanutF422C63273Z2026-07-29
00810053950463NOVEOS Ara h 2, PeanutF423C63274-3Z2026-07-29
00810053950494NOVEOS Ara h 6, PeanutF447C63399Z2026-07-29
00816879023770NOVEOS Sesame Seed, Sesamum indicumF01086322702026-07-29
00816879024203NOVEOS Lobster, Homarus gammarusF08086325202026-07-29
00816879024333NOVEOS Ara h 1, PeanutF422C632732026-07-29
00816879024470NOVEOS Bos d 8 Casein, MilkF078C63250-32026-07-29
00816879024982NOVEOS Ara h 2, PeanutF423C63274-32026-07-29
00816879025323NOVEOS Ara h 8 PR-10, PeanutF352C633432026-07-29
00816879025354NOVEOS Soybean, Glycine maxF014632302026-07-29
00816879025378NOVEOS Ara h 6, PeanutF447C633992026-07-29
00816879027341NOVEOS Hazelnut, Corylus avellanaF017632322026-07-29
00816879027969NOVEOS Almond, Amygdalus communisF02086340402026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04049016108856EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016108863EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016119920EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016135883EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016135890EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016135968EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
07333066014630EliA GBM WellPhadia ABMVJ2016-09-23
07333066010670EliA GBM WellPhadia ABMVJ2016-09-23
05391516747943Trinity BiotechMARDX DIAGNOSTICS, INC.MVJ2016-09-19
00813545022938GBM P KDY Test(L) 48 SCIMEDX CORPORATIONMVJ2016-09-19
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05391516747585Trinity BiotechMARDX DIAGNOSTICS, INC.MVJ2016-09-18
05391516748001Trinity BiotechMARDX DIAGNOSTICS, INC.MVJ2016-09-18
05391516748018Trinity BiotechMARDX DIAGNOSTICS, INC.MVJ2016-09-18
00813545020583P KDY Pack 4 WELLSCIMEDX CORPORATIONMVJ2016-09-16
00813545020606P KDY Pack 8 WELLSCIMEDX CORPORATIONMVJ2016-09-16
00847865000536BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
00847865002387BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
00847865002394BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
00847865010955BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
00847865011082BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
08426950454533QUANTA Lite® GBM ELISA INOVA DIAGNOSTICS, INC.MVJ2016-08-31
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