FDA.reportPublic FDA data

AutoDELFIA Neonatal IRT kit

Primary DI
06438147298716
Brand
AutoDELFIA Neonatal IRT kit
Company
Wallac Oy
Model
B005-212
Catalog number
B005-212
Device description
For the quantitative determination of immunoreactive trypsin (IRT) in dried blood.
Published
2016-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JNON-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JNON-Benzoyl-L-Arginine Ethyl Ester (U.V.), TrypsinClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110274000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110274000AUTODELFIA NEONATAL IRT KITWallac Oy, A Subsidiary of Perkinelmer, Inc.2011-06-10JNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147298716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147298716064381472987166438147298716

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal trypsin IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of neonatal trypsin in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540156544
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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06438147411672NeoLSD MSMS kit3093-004U3093-004U2025-08-15
06438147179596AutoDELFIA Neonatal hTSH kitB032-02CB032-02C2016-02-02
06438147179602AutoDELFIA Neonatal Thyroxine (T4) kitB065-01CB065-01C2016-02-02
06438147292479AutoDELFIA Neonatal 17α-OH-progesterone kitB024-01CB024-01C2018-11-16
06438147344406AutoDELFIA Inhibin A kit Level Calibrators B064-112-P2B064-112-P22018-11-21
06438147344420AutoDELFIA Inhibin A kit B064-112B064-1122017-10-10
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06438147377756Eonis SCID-SMA kit3242-001U3242-001U2022-11-30
06438147121373VICTOR2 D1420-0211420-0212019-03-19
06438147333202VICTOR EnLite1420-02201420-02202019-03-19
06438147333219VICTOR EnLite1420-02301420-02302019-03-19
06438147064540Wallac Plate Shake1296-0041296-0042019-02-25
06438147009176DELFIA hCG kitA007-101A007-1012016-02-11
06438147009343AutoDELFIA hCG kitB007-112B007-1122016-02-11
06438147391998DBS Controls LysoPC3413-00103413-00102024-01-08
06438147392339LysoPC IS4417-00104417-00102024-01-08
06438147009336AutoDELFIA hCG kit B007-101B007-1012016-02-11
06438147356218NeoLSD MSMS kit3093-001U3093-001U2018-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04099466112248Pancreatic Elastase ELISASeramun Diagnostica GmbHJNO2024-11-21
00817830023228MP Biomedicals LLCMp Biomedicals, LLCJNO2023-08-03
00817830023235MP Biomedicals LLCMp Biomedicals, LLCJNO2023-08-03
03770024321579TRYPS-USCISBIO BIOASSAYSJNO2021-12-07
05400569001411Trypsin-RIADiasource Immunoassays S.A. SAJNO2020-01-29
06438147298785AutoDELFIA Neonatal IRT kit Wallac OyJNO2016-02-02
06438147320523GSP Neonatal IRT kitWallac OyJNO2016-01-12