FDA.reportPublic FDA data

Atellica IM CEA DIL

Primary DI
00630414598529
Brand
Atellica IM CEA DIL
Company
Siemens Healthcare Diagnostics Inc.
Model
10995525
Catalog number
10995525
Device description
CEA Diluent Atellica IM - CONS - (2PK) 2 x 5mL
Published
2017-12-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DHXSYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHXSystem, Test, Carcinoembryonic AntigenImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981478000ACS:CENTAUR CEAChiron Diagnostics Corp.1998-08-12DHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414598529PrimaryGS10
00630414007427Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598529006304145985296304145985290630414598529
00630414007427006304140074276304140074270630414007427

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, automated/semi-automated systemA buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. Some types may, in addition be used for manual procedures.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
064608573
Device count
2
Lot or batch
true
Expiration date on label
true

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