FDA.report

Synchron

Primary DI
15099590209032
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
A95550
Catalog number
A95550
Device description
Lactate Reagent (LACT 2 x 50)
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Product Code Classifications

CodeDeviceSpecialtyClass
CFJNad Reduction/Nadh Oxidation, Lactate DehydrogenaseClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590209032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959020903215099590209032

GMDN Terms

TermDefinition
Total lactate dehydrogenase (LDH) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total lactate dehydrogenase (LDH) in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008254708
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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