FDA.reportPublic FDA data

Atellica IM ThCG

Primary DI
00630414294254
Brand
Atellica IM ThCG
Company
Siemens Healthcare Diagnostics Inc.
Model
11206261
Catalog number
11206261
Device description
HCG Total (ThCG) - Atellica IM - RGT - 450T
Published
2020-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JHIVisual, pregnancy hCG, prescription use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHIVisual, Pregnancy Hcg, Prescription UseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172322000Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.2018-03-29JHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414293776PrimaryGS10
00630414294254Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414293776006304142937766304142937760630414293776
00630414294254006304142942546304142942540630414294254

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright, Protect from light
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
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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