FDA.reportPublic FDA data

Aldolase

Primary DI
04015630990641
Brand
Aldolase
Company
Roche Diagnostics GmbH
Model
10123838160
Catalog number
10123838160
Published
2021-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CJCFRUCTOSE-1, 6-DIPHOSPHATE AND NADH (U.V.), ALDOLASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJCFructose-1, 6-Diphosphate And Nadh (U.V.), AldolaseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630990641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630990641040156309906414015630990641

GMDN Terms#

Term, Definition table
TermDefinition
Aldolase IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of aldolase in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817302024654Caldon Biotech Aldolase ReagentCAROLINA LIQUID CHEMISTRIES CORPORATIONCJC2022-11-30
05055273200072ALDOLASE (ALS)RANDOX LABORATORIES LIMITEDCJC2019-05-31