FDA.reportPublic FDA data

ClearChem Diagnostics Inc. Lactate Dehydogenase (LDH)

Primary DI
00852169008195
Brand
ClearChem Diagnostics Inc. Lactate Dehydogenase (LDH)
Company
CLEARCHEM DIAGNOSTICS INC.
Model
LDH1170
Catalog number
LDH1170
Device description
In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL
Published
2018-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00852169008195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852169008195008521690081958521690081950852169008195

GMDN Terms#

Term, Definition table
TermDefinition
Total lactate dehydrogenase (LDH) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total lactate dehydrogenase (LDH) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume225Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Refrigerated
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(714)734-8041dwheat@clearchem.net

Regulatory Flags#

DUNS number
010655581
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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00852169008072ClearChem Diagnostics Inc. Carbon Dioxide (CO2)CAR1090CAR10902018-04-30
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00852169008034ClearChem Diagnostics Inc. Alanine aminotransferase (ALT)ALT1020ALT10202018-04-30
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