FDA.reportPublic FDA data

ADVIA® Chemistry LAC Lactate Reagents

Primary DI
00630414475660
Brand
ADVIA® Chemistry LAC Lactate Reagents
Company
Siemens Healthcare Diagnostics Inc.
Model
10325776
Catalog number
B01-4818-01
Device description
Lactate - ADVIA Chem. - RGT - 3x100 tests
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
CFJNAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFJNad Reduction/Nadh Oxidation, Lactate DehydrogenaseClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414475660PrimaryGS10
00630414003580Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414475660006304144756606304144756600630414475660
00630414003580006304140035806304140035800630414003580

GMDN Terms#

Term, Definition table
TermDefinition
Lactate IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of lactate in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
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
3
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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