FDA.reportPublic FDA data

Autostat II Anti-Nuclear Antibody (ANA) Screen

Primary DI
00816879020212
Brand
Autostat II Anti-Nuclear Antibody (ANA) Screen
Company
HYCOR BIOMEDICAL LLC
Model
FGA21
Device description
96 well ELISA for the detection of anti-nuclear 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
LIMTest, Screening, For D Positive Fetal Rbc'S

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIMTest, Screening, For D Positive Fetal Rbc'SHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983655000AUTOSTAT II ANA SCREEN ELISACogent Diagnotics , Ltd.1999-01-28LJM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816879020212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879020212008168790202128168790202120816879020212

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)A 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 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
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
00810053950388NOVEOS Gal d 2 Ovalbumin, EggF232C63265Z2026-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LIM2023-12-14
10888234000907FMH RapidScreenIMMUCOR, INC.LIM2016-04-14