ASI Staphslide Test

Primary DI
00816057020102
Brand
ASI Staphslide Test
Company
ARLINGTON SCIENTIFIC, INC.
Model
NC-280-2C
Catalog number
NC-280-2C
Device description
Detection of coagulase associated with Staph. aureus
Published
2016-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWXKit, Screening, Staphylococcus Aureus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWXKit, Screening, Staphylococcus AureusMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K855220000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K855220000V-TREND KIT STAPH LATEX TESTTexas Immunology, Inc.1986-03-03JWX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816057020102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816057020102008160570201028160570201020816057020102

GMDN Terms#

Term, Definition table
TermDefinition
Staphylococcus aureus culture isolate antigen IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Staphylococcus aureus bacteria isolated by culture from a clinical specimen, using an agglutination method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
801-489-8911info@arlingtonscientific.com

Regulatory Flags#

DUNS number
785966607
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00816057020041ASiManager-ATNC-2400-0BTNC-2400-0BT2016-07-08
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