FDA.reportPublic FDA data

Neonatal Phenylalanine ELISA Kit (without membrane)

Primary DI
00817830022344
Brand
Neonatal Phenylalanine ELISA Kit (without membrane)
Company
MP BIOMEDICALS, LLC
Model
07575305
Catalog number
07575305
Device description
ELISA kit for the quantitative detection of phenylalanine in neonatal blood spots.
Published
2016-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K926106000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K926106000IMMUCHEM PHE-MW EAIcn Biomedicals, Inc.1995-02-08JNB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817830022344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817830022344008178300223448178300223440817830022344

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of neonatal thyroid stimulating hormone (neonatal TSH) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25.5Centimeter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-0530custserv@mpbio.com

Regulatory Flags#

DUNS number
137825928
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
00817830023211MP Biomedicals LLC07189105071891052023-08-03
00817830023228MP Biomedicals LLC07596303075963032023-08-03
00817830023235MP Biomedicals LLC07596307075963072023-08-03
00817830023006MP Biomedicals LLC06B25501706B2550172023-08-02
00817830023075MP Biomedicals LLC07140202071402022023-08-02
00817830023082MP Biomedicals LLC07140205071402052023-08-02
00817830023099MP Biomedicals LLC07553300075533002023-08-02
00817830023105MP Biomedicals LLC07553303075533032023-08-02
00817830023112MP Biomedicals LLC07553305075533052023-08-02
00817830023129MP Biomedicals LLC07553306075533062023-08-02
00817830023136MP Biomedicals LLC06B25502506B2550252023-08-02
00817830023143MP Biomedicals LLC07152101071521012023-08-02
00817830023150MP Biomedicals LLC07171102071711022023-08-02
00817830023167MP Biomedicals LLC07170102071701022023-08-02
00817830023174MP Biomedicals LLC07170105071701052023-08-02
00817830023181MP Biomedicals LLC07270102072701022023-08-02
00817830023198MP Biomedicals LLC07270105072701052023-08-02
00817830023204MP Biomedicals LLC07189102071891022023-08-02
00817830023013MP Biomedicals LLC07109202071092022023-08-01
00817830023020MP Biomedicals LLC07230102072301022023-08-01

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
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
06438147001293Neonatal Phenylalanine kitWallac OyJNB2016-02-02