FDA.report

Alinity

Primary DI
00380740165314
Brand
Alinity
Company
ABBOTT LABORATORIES
Model
08P6301
Catalog number
08P6301
Device description
Alinity c DOA MC Qual Low Calibrator 1 Kit
Published
2019-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DKBCalibrators, drug mixture

Product Code Classifications

CodeDeviceSpecialtyClass
DKBCalibrators, Drug MixtureClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00380740165314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740165314003807401653143807401653140380740165314

GMDN Terms

TermDefinition
Multiple drugs of abuse IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature030 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
079226220
Device count
1
DM exempt
false
Premarket exempt
true
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

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