FDA.report

Serum Control

Primary DI
04250317533487
Brand
Serum Control
Company
Chromsystems Instruments + Chemicals GmbH
Model
0347
Catalog number
0347
Device description
MassCheck® Steroid Panel 2, Serum Control Level III
Published
2020-08-06
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
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250317533487PackageGS15In Commercial Distribution
04250317545572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250317533487042503175334874250317533487
04250317545572042503175455724250317545572

GMDN Terms

TermDefinition
Multiple steroid hormone 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 one or multiple steroid hormones in a clinical specimen.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-18 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+4989189300mailbox@chromsystems.de

Regulatory Flags

DUNS number
328712260
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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