FDA.reportPublic FDA data

Neonatal Phenylalanine kit

Primary DI
06438147001293
Brand
Neonatal Phenylalanine kit
Company
Wallac Oy
Model
NP-4000
Catalog number
NP-4000
Device description
For the quantitative determination of phenylalanine 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
JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), PhenylalanineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943547000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943547000PHENYLALANINE TEST KITIsolab, Inc.1996-01-26JNB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147001293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147001293064381470012936438147001293

GMDN Terms#

Term, Definition table
TermDefinition
Phenylalanine IVD, kit, fluorimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of phenylalanine in a clinical specimen, using a fluorimetry 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

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Primary DI, Brand, Model table
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06438147292479AutoDELFIA Neonatal 17α-OH-progesterone kitB024-01CB024-01C2018-11-16
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06438147121373VICTOR2 D1420-0211420-0212019-03-19
06438147333202VICTOR EnLite1420-02201420-02202019-03-19
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00725609000601SPOTCHECKASTORIA-PACIFIC, INC.JNB2020-12-17
00817830022320Neonatal Phenylalanine ELISA Kit (without membrane)MP BIOMEDICALS, LLCJNB2016-10-20
00817830022337Neonatal Phenylalanine ELISA Kit (with membrane)MP BIOMEDICALS, LLCJNB2016-10-20
00817830022344Neonatal Phenylalanine ELISA Kit (without membrane)MP BIOMEDICALS, LLCJNB2016-10-20
00817830022351Neonatal Phenylalanine ELISA Kit (with membrane)MP BIOMEDICALS, LLCJNB2016-10-20
00725609000007SPOTCHECKASTORIA-PACIFIC, INC.JNB2016-10-14
00847817021527QuantaseBIO-RAD LABORATORIES, INC.JNB2016-09-12
06438147001286Neonatal Phenylalanine kitWallac OyJNB2016-02-02