FDA.report

Atellica IM IRI DIL

Primary DI
00630414600475
Brand
Atellica IM IRI DIL
Company
Siemens Healthcare Diagnostics Inc.
Model
10995631
Catalog number
10995631
Device description
Insulin (IRI) Diluent Bottle Atellica IM - CONS) 1 x 10mL
Published
2020-09-24
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

Related Records

Product Codes

CodeName
CFPRADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN

Product Code Classifications

CodeDeviceSpecialtyClass
CFPRadioimmunoassay, Immunoreactive InsulinClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00630414600475PrimaryGS10

GMDN Terms

TermDefinition
Buffered sample diluent IVD, manualA buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags

DUNS number
064608573
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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