FDA.report

ARCHITECT

Primary DI
00380740163372
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
1E49-21
Catalog number
01E4921
Device description
ICT Reference Solution
Published
2019-08-15
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
CGZELECTRODE, ION-SPECIFIC, CHLORIDE

Product Code Classifications

CodeDeviceSpecialtyClass
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00380740163372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740163372003807401633723807401633720380740163372

GMDN Terms

TermDefinition
Ion selective electrode (ISE) reference solution IVD, reagentA substance or reactant intended to be used together with a reference electrode to perform a specific function in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
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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