FDA.reportPublic FDA data

ADVIA Centaur Herpes-2 IgG

Primary DI
00630414016726
Brand
ADVIA Centaur Herpes-2 IgG
Company
Siemens Healthcare Diagnostics Inc.
Model
10720849
Catalog number
10720849
Device description
Herpes-2 IgG (HSV2) ADVIA Centaur - RGT – 100T
Published
2019-04-09
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
LGCEnzyme linked immunoabsorbent assay, herpes simplex virus, non-specific
MYFEnzyme linked immunosorbent assay, herpes simplex virus, hsv-2

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-SpecificMicrobiology2
MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181334000ADVIA Centaur Herpes-2 IgGBiokit, S.A.2018-08-23MYF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414016726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414016726006304140167266304140167260630414016726

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to herpes simplex virus 2 (HSV2) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

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