FDA.reportPublic FDA data

Lysozyme ELISA

Primary DI
04050598000452
Brand
Lysozyme ELISA
Company
Immundiagnostik AG
Model
K 6902
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JMQM. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMQM. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050598000452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050598000452040505980004524050598000452

GMDN Terms#

Term, Definition table
TermDefinition
Lysozyme (muramidase) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the bacteriolytic enzyme lysozyme (muramidase) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
321663841
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04050598163300Albumin ELISAK 63302023-06-21
04050598008540IDK® Pancreatic Elastase ELISAK 6915.20.US2023-06-21
04050598010420IDK® Pancreatic Elastase ELISAK 6915.US2023-06-21
04050598169906Chymotrypsin ActivityK 69902023-06-21
04050598000445Lysozyme ELISAK 69012023-06-21
04050598000469Lysozyme ELISAK 69032023-06-21
04050598000872α2-Makroglobulin ELISAK 6610A2023-06-21
04050598007673IDK® sIgA ELISAK 8870.20.US2023-06-21
04050598010406Lactoferrin ELISAK 6870.US2023-06-21
04050598010413Lactoferrin ELISAK 6870.20.US2023-06-21
04050598010437ox-LDL ELISAK 7810.US2023-06-21
04050598010444ox-LDL ELISAK 7810.20.US2023-06-21
04050598010451IDK® sIgA ELISAK 8870.US2023-06-21
04050598010468IDK Extract®K 6999.US2023-06-21
04050598010475Stool preparation system SASK 6998SAS.US2023-06-21
04050598010482Stool preparation system SASK 6998SAS.20.US2023-06-21
04050598010499Retinol-binding protein RBP/RBP4 ELISAK 6110.US2023-06-21
04050598010505Retinol-binding protein RBP/RBP4 ELISAK 6110.20.US2023-06-21
04050598010512IDK Extract®K 6999.17.US2023-06-21
04050598010529IDK Extract®K 6999.20.US2023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474060904Dengue Virus NS1 Ag ELISADRG Instruments Gesellschaft mit beschränkter HaftungJMQ2023-09-01
04048474061000Lysozyme (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJMQ2023-09-01
00840239061003Lysozyme (stool) ELISA DRG International IncJMQ2023-08-26
04050598000445Lysozyme ELISAImmundiagnostik AGJMQ2023-06-21
04050598000469Lysozyme ELISAImmundiagnostik AGJMQ2023-06-21
04050598169005Lysozym ELISAImmundiagnostik AGJMQ2023-06-21
00404847461008Lysozyme (stool) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJMQ2021-06-07