FDA.reportPublic FDA data

Autostat II Anti-Sm

Primary DI
00816879020311
Brand
Autostat II Anti-Sm
Company
HYCOR BIOMEDICAL LLC
Model
FGA31
Device description
96 well ELISA for the detection of Anti-Sm 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
LKPAnti-Sm Antibody, Antigen And Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKPAnti-Sm Antibody, Antigen And ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990625000AUTOSTAT II ANTI-SM ELISACogent Diagnotics , Ltd.1999-04-28LKP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816879020311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879020311008168790203118168790203110816879020311

GMDN Terms#

Term, Definition table
TermDefinition
Smith antibody (anti-Sm) 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-Smith (anti-Sm) 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
Primary DIBrandModelCatalogPublished
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaF0188632330Z2026-05-29
00810053950203NOVEOS Coconut, Cocos nuciferaF0368634210Z2026-05-29
00810053950210NOVEOS Tuna, Thunnus sp.F0408632420Z2026-05-29
00810053950227NOVEOS Salmon, Salmo salarF0418638910Z2026-05-29
00810053950265NOVEOS Egg Yolk, Gallus gallusF07563247Z2026-05-29
00810053950340NOVEOS Pecan Nut, Carya illinoensisF2018633630Z2026-05-29
00810053950364NOVEOS Pistachio Nut, Pistacia veraF2038632630Z2026-05-29
00810053950418NOVEOS Oyster, Ostrea edulisF2908633830Z2026-05-29
00816879023794NOVEOS Brazil Nut, Bertholletia excelsaF01886323302026-05-29
00816879023824NOVEOS Tuna, Thunnus sp.F04086324202026-05-29
00816879023886NOVEOS Pistachio Nut, Pistacia veraF20386326302026-05-29
00816879024548NOVEOS Salmon, Salmo salarF04186389102026-05-29
00816879024760NOVEOS Pecan Nut, Carya illinoensisF20186336302026-05-29
00816879025057NOVEOS Oyster, Ostrea edulisF29086338302026-05-29
00816879025149NOVEOS Egg Yolk, Gallus gallusF075632472026-05-29
00816879027372NOVEOS Coconut, Cocos nuciferaF03686342102026-05-29
00816879020212Autostat II Anti-Nuclear Antibody (ANA) ScreenFGA212016-09-26
00810053950098NOVEOS Peanut, Arachis hypogaeaF01363229Z2026-01-22
00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkF076C63248Z2026-01-22
00810053950289NOVEOS Bos d 5 b-lactoglobulin, MilkF077C63249-3Z2026-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LKP2023-12-14
07333066021485EliA SmDP-S WellPhadia ABLKP2021-07-20
07333066017709EliA SmDP-S WellPhadia ABLKP2021-07-20
04049016027027Anti-Sm ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
04049016083139EUROLINE ENA ProfilePlus 4 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
04049016084785EUROLINE ENA ProfilePlus 4 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
04049016124900EUROLINE ENA Profile 9 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
04049016124917EUROLINE ENA Profile 9 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
07333066014838EliA SmDP WellPhadia ABLKP2016-09-23
07333066010885EliA SmDP WellPhadia ABLKP2016-09-23
00847661000150LiquichekBIO-RAD LABORATORIES, INC.LKP2016-09-12
00847817022449Autoimmune EIABIO-RAD LABORATORIES, INC.LKP2016-09-12
08426950595533QUANTA Flash® Sm ReagentsINOVA DIAGNOSTICS, INC.LKP2016-08-31
00850487007050ReQuest QUEST INTERNATIONAL, INC.LKP2016-08-31
00850487007265ReQuestQUEST INTERNATIONAL, INC.LKP2016-08-31
00850487007593SeraQuestQUEST INTERNATIONAL, INC.LKP2016-08-31
07340058410028DIASTAT anti-Sm/RNPSvar Life Science ABLKP2016-08-12
07340058410059DIASTST anti-SmSvar Life Science ABLKP2016-08-12