FDA.reportPublic FDA data

DG Spin

Primary DI
08437014205152
Brand
DG Spin
Company
DIAGNOSTIC GRIFOLS SA
Model
210363
Catalog number
210363
Device description
DG SPIN Centrifugue is a device specifically designed to centrifuge DG Gel 8 cards.
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
BK1200450

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1200450

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437014205152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437014205152084370142051528437014205152

GMDN Terms#

Term, Definition table
TermDefinition
Gel column agglutination centrifuge IVDAn electrically-powered device intended to be used in a clinical laboratory setting for the centrifugation of gel column agglutination cards used to perform manual blood typing assays. It is a dedicated compact benchtop unit with an electric motor, a shaft, a rotor with slots specifically shaped for use with gel column cards, and speed and time controls. The device is intended to centrifuge gel column agglutination cards for the manual determination of antigens of multiple blood systems (e.g., ABO, Rh, Kell) for compatibility testing and detection of unexpected antibodies.

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
08437014205169DG Therm2137342137342016-09-06

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
08437014205169DG ThermDIAGNOSTIC GRIFOLS SAPBC2016-09-06
08437014205176DG ReaderDIAGNOSTIC GRIFOLS SAPBC2016-09-06