ADVIA® Chemistry IRON_2 Reagents

Primary DI
00630414513157
Brand
ADVIA® Chemistry IRON_2 Reagents
Company
Siemens Healthcare Diagnostics Inc.
Model
10341118
Catalog number
10341118
Device description
Iron - ADVIA Chem. - RGT - 7x145 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
JIYPhotometric method, iron (non-heme)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIYPhotometric Method, Iron (Non-Heme)Clinical 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
00630414513157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414513157006304145131576304145131570630414513157

GMDN Terms#

Term, Definition table
TermDefinition
Iron IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of iron 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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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
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00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
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00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
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Primary DI, Brand, Company table
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