FDA.reportPublic FDA data

Galactose (without Membrane Plate) ELISA

Primary DI
00840239014894
Brand
Galactose (without Membrane Plate) ELISA
Company
DRG International Inc
Model
EIA-1489
Catalog number
EIA-1489
Device description
The DRG neonatal Galactose ELISA is designed for the quantitative determination of galactose in neonatal blood spots. It is for in vitro diagnostic use as an aid in screening newborns for elevated galactose levels as seen in galactosemia.
Published
2021-06-07
Public version status
Update
Distribution status
Not 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
JIAENZYMATIC METHODS, GALACTOSE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIAEnzymatic Methods, GalactoseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951329000IMMUCHEM GAL-MW EAIcn Pharmaceuticals, Inc.1995-11-09JIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239014894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239014894008402390148948402390148940840239014894

GMDN Terms#

Term, Definition table
TermDefinition
Total galactose IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total galactose (galactose and galactose-1-phosphate) in a clinical specimen, using an enzyme spectrophotometry method.

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(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
Kit
true
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
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817830023099MP Biomedicals LLCMp Biomedicals, LLCJIA2023-08-02
00817830023105MP Biomedicals LLCMp Biomedicals, LLCJIA2023-08-02
00817830023112MP Biomedicals LLCMp Biomedicals, LLCJIA2023-08-02
00817830023129MP Biomedicals LLCMp Biomedicals, LLCJIA2023-08-02
00840239014863Galactose (with Membrane Plate) ELISADRG International IncJIA2021-06-07
00840239014870Galactose (without Membrane Plate) ELISADRG International IncJIA2021-06-07
00840239014887Galactose (with Membrane Plate) ELISADRG International IncJIA2021-06-07
06438147367917GSP Neonatal Total Galactose kitWallac OyJIA2021-06-04
00725609000595SPOTCHECKASTORIA-PACIFIC, INC.JIA2020-12-17
06438147275281Neonatal Total Galactose kit Wallac OyJIA2017-05-02
06438147328031GSP Neonatal Total Galactose Kit Wallac OyJIA2017-05-02
00725609000090SPOTCHECKASTORIA-PACIFIC, INC.JIA2016-10-14
00725609000106SPOTCHECKASTORIA-PACIFIC, INC.JIA2016-10-14
00725609000199AccuwellASTORIA-PACIFIC, INC.JIA2016-10-14