FDA.reportPublic FDA data

Dimension® AHDL CAL

Primary DI
00842768022012
Brand
Dimension® AHDL CAL
Company
Siemens Healthcare Diagnostics Inc.
Model
10464328
Catalog number
DC48B
Device description
AHDL Calibrator, 2x3x1mL
Published
2016-09-24
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
JITCALIBRATOR, SECONDARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983850000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983850000DIMENSION AHDL CALIBRATORDade Behring, Inc.1998-11-18JIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768022012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768022012008427680220128427680220120842768022012

GMDN Terms#

Term, Definition table
TermDefinition
High-density lipoprotein (HDL) cholesterol IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of high-density lipoprotein (HDL) cholesterol lipid in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

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00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
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