FDA.report

ARCHITECT

Primary DI
00380740010478
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
6K26-21
Catalog number
06K2621
Device description
CRP Control HS
Published
2016-09-09
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
JJYMulti-analyte controls, all kinds (assayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00380740010478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740010478003807400104783807400104780380740010478

GMDN Terms

TermDefinition
C-reactive protein (CRP) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of C-reactive protein (CRP) in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature029 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
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
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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