Atellica CH Barbiturates (BrbC)

Primary DI
00630414654065
Brand
Atellica CH Barbiturates (BrbC)
Company
Siemens Healthcare Diagnostics Inc.
Model
11701325
Catalog number
11701325
Device description
Barbiturates (BrbC) Atellica CH - RGT 380T
Published
2025-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DISEnzyme immunoassay, barbiturate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010934000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010934000EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229Syva Co., Dade Behring, Inc.2001-04-20DIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414654065PrimaryGS10
00630414321936Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414654065006304146540656304146540650630414654065
00630414321936006304143219366304143219360630414321936

GMDN Terms#

Term, Definition table
TermDefinition
Barbiturate IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of barbiturates in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+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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