FDA.reportPublic FDA data

Autostat II Anti-Cardiolipin Screen

Primary DI
00816879020182
Brand
Autostat II Anti-Cardiolipin Screen
Company
HYCOR BIOMEDICAL LLC
Model
FGA18
Device description
96 well ELISA for the detection of anti-cardiolipin 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
MIDSystem, Test, Anticardiolipin Immunological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIDSystem, Test, Anticardiolipin ImmunologicalImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993085000AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISACogent Diagnotics , Ltd.2000-02-01MID

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816879020182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879020182008168790201828168790201820816879020182

GMDN Terms#

Term, Definition table
TermDefinition
Anticardiolipin 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 one or multiple classes of antibodies to cardiolipin 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

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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
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00816879027372NOVEOS Coconut, Cocos nuciferaF03686342102026-05-29
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00810053950098NOVEOS Peanut, Arachis hypogaeaF01363229Z2026-01-22
00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkF076C63248Z2026-01-22
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