FDA.reportPublic FDA data

DG Therm

Primary DI
08437014205169
Brand
DG Therm
Company
DIAGNOSTIC GRIFOLS SA
Model
213734
Catalog number
213734
Device description
DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology applications.
Published
2016-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBCManual Blood Grouping And Antibody Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBCManual Blood Grouping And Antibody Test SystemsHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1200460

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1200460

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437014205169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437014205169084370142051698437014205169

GMDN Terms#

Term, Definition table
TermDefinition
Microplate/tube/assay card incubator IVDAn electrically-powered device intended to be used for the uniform heating of the contents of a microplate, test tube, and/or assay/reagent/test card, as part of an incubation step required during the in vitro diagnostic processing of a clinical specimen. It typically consists of a heat-conducting panel/unit on which the microplate/tube/card is placed, and an electronically-controlled heating element for precise temperature control. It may also be referred to as a heater and may be used as a stand-alone device or a modular component as part of a system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)452-6877service.americas@grifols.com

Regulatory Flags#

DUNS number
463625602
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436583731802DG Gel Anti-K2102252102252026-05-26
08436583730478DG Gel AB (x4)2103462103462026-05-25
08436583731888Grifols Wash Solution A2136822136822026-03-13
08436583731895Grifols Wash Solution B2136832136832026-03-13
08437014205008DG Gel 8 Neutral2103932103932020-11-16
08437014205244Grifols Diluent2136772136772016-09-06
08436583731024DG Gel 8 Anti-D2102022102022022-10-10
08436583731031DG Gel 8 Anti-AB2102002102002022-10-10
08436583731055DG Gel 8 Anti-C2102012102012022-10-10
08436583731062DG Gel 8 Anti-E2102242102242022-10-10
08436583731079DG Gel 8 Anti-c2102262102262022-10-10
08436583731086DG Gel 8 Anti-e2102272102272022-10-10
08436583731093DG Gel 8 Rh Pheno2102282102282022-08-12
08437014205909DG Gel 8 Direct Coombs2101292022-07-08
08437014205060DG Gel 8 Anti-IgG (Rabbit)2103942103942015-07-22
08437014205947DG Gel 8 AB (x4)2103862103862021-03-15
08437014205930DG Gel 8 A/B/D2103842103842021-01-21
08437014205916DG Gel 8 ABO/Rh (2D)2101282101282020-05-06
08437014205220Erytra2104002104002019-05-20
08437014205152DG Spin2103632103632016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07611969226320IH-Centrifuge LBio-Rad Medical Diagnostics GmbHPBC2018-04-05
07611969226344IH-Incubator LBio-Rad Medical Diagnostics GmbHPBC2018-04-05
08437014205152DG SpinDIAGNOSTIC GRIFOLS SAPBC2016-09-06
08437014205176DG ReaderDIAGNOSTIC GRIFOLS SAPBC2016-09-06