FDA.reportPublic FDA data

Quantase

Primary DI
00847817021527
Brand
Quantase
Company
BIO-RAD LABORATORIES, INC.
Model
532-5040
Catalog number
5325040
Device description
Quantase Neonatal Accessory Kit 5 Elution Buffer
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K963040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963040000MANUAL PHENYLALANINE TESTBio-Rad1996-10-01JNB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817021527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817021527008478170215278478170215270847817021527

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723diagcs@bio-rad.com

Regulatory Flags#

DUNS number
132528295
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

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
06438147001286Neonatal Phenylalanine kitWallac OyJNB2016-02-02
06438147001293Neonatal Phenylalanine kitWallac OyJNB2016-02-02