FDA.reportPublic FDA data

Triglycerides/Glycerol Blanked

Primary DI
04015630992362
Brand
Triglycerides/Glycerol Blanked
Company
Roche Diagnostics GmbH
Model
11877771216
Catalog number
11877771216
Published
2021-02-08
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
CDTLIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K873049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K873049000TRIGLYCERIDES GPO WITHOUT FREE GLYCEROLBoehringer Mannheim Corp.1987-08-28CDT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630992362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630992362040156309923624015630992362

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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Primary DI, Brand, Company table
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