ADVIA® Chemistry MG Magnesium Reagents

Primary DI
00630414508429
Brand
ADVIA® Chemistry MG Magnesium Reagents
Company
Siemens Healthcare Diagnostics Inc.
Model
10309506
Catalog number
10309506
Device description
Magnesium - ADVIA Chem. - RGT - 7x140 tests
Published
2020-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CFOTITRIMETRIC, MAGNESIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFOTitrimetric, MagnesiumClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991576000ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp.1999-06-30CIX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414508429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414508429006304145084296304145084290630414508429

GMDN Terms#

Term, Definition table
TermDefinition
Magnesium (Mg2+) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of magnesium (Mg2+) in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
064608573
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414209845ADVIA® Chemistry MG Magnesium ReagentsSiemens Healthcare Diagnostics Inc.CFO2020-09-24
00630414526713ADVIA® Chemistry MG_c Magnesium Reagents, ConcentratedSiemens Healthcare Diagnostics Inc.CFO2020-09-24