AccessGUDID - DEVICE: IDS-iSYS Ostase® BAP (05060169695801)

GUDID

Device Identifier (DI) Information

Brand Name: IDS-iSYS Ostase® BAP
Version or Model: IS-2800US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMMUNODIAGNOSTIC SYSTEMS LIMITED

Primary DI Number: 05060169695801
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 494268600 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52932	Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of bone alkaline phosphatase (BALP) in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used as a marker for osteoblastic activity to aid in the diagnosis and/or management of metabolic bone diseases (e.g., osteoporosis, Paget’s disease).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200475	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Store the cartridge in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0c935c8d-c7ee-4d47-abb9-ae656d1eb3ec
Public Version Date: March 08, 2022
Public Version Number: 2
DI Record Publish Date: March 08, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +4401915190
Email: techsupport.uk@idsplc.com

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