FDA.report

Atellica IM LH MCM

Primary DI
00630414599540
Brand
Atellica IM LH MCM
Company
Siemens Healthcare Diagnostics Inc.
Model
10995636
Catalog number
10995636
Device description
Luteinizing Hormone (LH) Atellica IM - Master Curve Material Kit 10 x 1 x 1.0mL
Published
2020-09-24
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

Related Records

Contact Domains

Product Codes

CodeName
CEPRADIOIMMUNOASSAY, LUTEINIZING HORMONE
JJXSingle (specified) analyte controls (assayed and unassayed)

Product Code Classifications

CodeDeviceSpecialtyClass
CEPRadioimmunoassay, Luteinizing HormoneClinical Chemistry1
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00630414599540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414599540006304145995406304145995400630414599540

GMDN Terms

TermDefinition
Luteinizing hormone (LH) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of luteinizing hormone (LH) in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
064608573
Device count
1
DM exempt
false
Premarket exempt
true
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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