FDA.reportPublic FDA data

Alinity

Primary DI
00380740167493
Brand
Alinity
Company
Abbott GmbH & Co. KG
Model
06P0720
Catalog number
06P0720
Device description
Alinity s HTLV I/II Assay Control Kit
Published
2019-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740167493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740167493003807401674933807401674930380740167493

GMDN Terms#

Term, Definition table
TermDefinition
Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, controlA material which is used to verify the performance of an assay that is used for the qualitative and/or quantitative detection of antibodies to human T-cell lymphotrophic virus 1 and 2 (HTLV1 and HTLV2) in a clinical specimen.

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
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
315786293
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740138332Alinity07P603107P60312020-05-29
00380740192457Alinity06R901A06R901A2020-05-18
00380740170264Alinity09P521A09P521A2020-05-11
00380740170271Alinity09P523A09P523A2020-05-11
00380740121754Alinity08P072108P07212020-05-06
00380740121778Alinity08P073108P07312020-05-06
00380740136574Alinity08P071208P07122020-05-06
00380740146252Alinity08P070208P07022020-05-06
00380740151744Alinity09P411A09P411A2020-05-01
00380740154387Alinity08P073A08P073A2020-05-01
00380740163556ARCHITECT5P56-0205P56022020-05-02
00380740161798ARCHITECT7D79-2207D79222020-04-18
00380740161804ARCHITECT7D79-3207D79322020-04-18
00380740190361ARCHITECT08K280408K28042020-04-15
00380740190378ARCHITECT08K281308K28132020-04-15
00380740154325Alinity09P140309P14032018-07-30
00380740174965ARCHITECT6L45-2206L45222020-04-12
00380740174972ARCHITECT6L45-4206L45422020-04-12
00380740170318Alinity09P551A09P551A2020-03-27
00380740170325Alinity09P553A09P553A2020-03-27