FDA.reportPublic FDA data

Neonatal TSH ELISA

Primary DI
00840239014832
Brand
Neonatal TSH ELISA
Company
DRG International Inc
Model
EIA-1483
Catalog number
EIA-1483
Device description
The DRG Neonatal TSH ELISA kit is specifically designed to quantitate human thyroid stimulating hormone from neonatal blood spot samples collected on Schleicher and Schuell’s filter paper #903.
Published
2019-06-10
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
JLWRADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLWRadioimmunoassay, Thyroid-Stimulating HormoneClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912324000NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAYBd Becton Dickinson Vacutainer Systems Preanalytic1991-06-20JLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239014832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239014832008402390148328402390148320840239014832

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.

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
Expiration date on label
true

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