FDA.reportPublic FDA data

Autostat II Anti-Sm/RNP

Primary DI
00816879020328
Brand
Autostat II Anti-Sm/RNP
Company
HYCOR BIOMEDICAL LLC
Model
FGA32
Device description
96 well ELISA for the detection of Anti-Sm/RNP 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
LKOAnti-Rnp Antibody, Antigen And Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKOAnti-Rnp Antibody, Antigen And ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990624000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990624000AUTOSTAT II ANTI-SM/RNP ELISACogent Diagnotics , Ltd.1999-04-28LKO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816879020328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879020328008168790203288168790203280816879020328

GMDN Terms#

Term, Definition table
TermDefinition
Sm/RNP 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 Sm/RNP antigen complex (anti-Sm/RNP) 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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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
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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

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