FDA.report

ARCHITECT

Primary DI
00380740001698
Brand
ARCHITECT
Company
Abbott GmbH & Co. KG
Model
1P29-01
Catalog number
01P2901
Device description
ARCHITECT iTheophylline Calibrators
Published
2016-06-06
Public version status
Update
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
DLJCALIBRATORS, DRUG SPECIFIC

Product Code Classifications

CodeDeviceSpecialtyClass
DLJCalibrators, Drug SpecificClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00380740001698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740001698003807400016983807400016980380740001698

GMDN Terms

TermDefinition
Theophylline therapeutic drug monitoring IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of the anti-asthma drug theophylline 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
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

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