ASI RF Direct Slide Test

Primary DI
00816057020508
Brand
ASI RF Direct Slide Test
Company
ARLINGTON SCIENTIFIC, INC.
Model
NC-7001000DC
Catalog number
NC-70010000DC
Device description
Detection of Rheumatoid Factor
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
DHRSystem, Test, Rheumatoid Factor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHRSystem, Test, Rheumatoid FactorImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K821319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K821319000SERO/TEX RF TESTTexas Immunology, Inc.1982-05-21DHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816057020508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816057020508008160570205088160570205080816057020508

GMDN Terms#

Term, Definition table
TermDefinition
Rheumatoid factor IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in 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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00816057021710ASI Evolution RPR Titration DiluentNC-5300-905ANC-5300-905A2023-12-19
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00816057020409ASI Rubella TestNC-600030NC-6000302016-07-08
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00816057020423ASI Rubella TestNC-600100NC-6001002016-07-08
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00816057020041ASiManager-ATNC-2400-0BTNC-2400-0BT2016-07-08
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