FDA.reportPublic FDA data

Atellica CH ECRE3

Primary DI
00630414301587
Brand
Atellica CH ECRE3
Company
Siemens Healthcare Diagnostics Inc.
Model
11537216
Catalog number
11537216
Device description
Enzymatic Creatinine_3 (ECre3) Atellica CH Assay 2000 Tests
Published
2022-09-30
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
JFYENZYMATIC METHOD, CREATININE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFYEnzymatic Method, CreatinineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212223000Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, Inc.2021-11-24JFY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414610948PrimaryGS10
00630414301587Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414610948006304146109486304146109480630414610948
00630414301587006304143015876304143015870630414301587

GMDN Terms#

Term, Definition table
TermDefinition
Creatinine IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of creatinine in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Store Upright
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005088112
Device count
4
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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