N-MID® Osteocalcin ELISA

GUDID 05060169690516

IMMUNODIAGNOSTIC SYSTEMS LIMITED

Osteocalcin IVD, kit, chemiluminescent immunoassay
Primary Device ID05060169690516
NIH Device Record Keyc6b0ea9e-d25c-4137-bcd3-3d6a52ad6626
Commercial Distribution StatusIn Commercial Distribution
Brand NameN-MID® Osteocalcin ELISA
Version Model NumberAC-11F1
Company DUNS494268600
Company NameIMMUNODIAGNOSTIC SYSTEMS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com
Phone+4401915190660
Emailinfo.uk@idsplc.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upon receipt at 2 to 8 degrees celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060169690516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEOSystem, Test, Osteocalcin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-04-01

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05060169696532 - IDS ACTH II Control Set2023-08-31
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05060169691261 - IDS Androstenedione2023-07-05

Trademark Results [N-MID]

Mark Image

Registration | Serial
Company
Trademark
Application Date
N-MID
N-MID
75232815 2183519 Live/Registered
IMMUNODIAGNOSTIC SYSTEMS LTD.
1997-01-29

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